Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01384721
Status:
RECRUITING
Last Update Posted:
2021-01-13
First Post:
2011-06-28
Brief Title:
Computed Tomography Coronary Angiography CTCA Prognostic Registry for Coronary Artery Disease
Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Organization:
Azienda Ospedaliero-Universitaria di Parma
Study Overview
Official Title:
Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease - CTCA-PRORECAD
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRORECAD
Brief Summary:
The study aims at pooling a large population of patients with suspected coronary artery disease CAD who underwent Computed Tomography Coronary Angiography CTCA and who were adequately stratified in the first place Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease non obstructiveobstructive and prognosis of patients with suspected CAD The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk
Detailed Description:
The Project aims at pooling retrospectively a large population of patients with suspected coronary artery disease CAD who underwent Computed Tomography Coronary Angiography CTCA and who were adequately stratified in the first place Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease non obstructiveobstructive and prognosis of patients with suspected CAD The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk
Primary objectives
MACEMajor Adverse Cardiovascular Events ie Cardiac Death Unstable Angina requiring Hospitalization Acute Myocardial Infarction
Prevalence of cardiovascular risk category shifting based on coronary plaque burden
Secondary objectives
Coronary Revascularizations occurred after CTCA ie PCIPercutaneous Coronary Revascularization and CABGCoronary Artery Bypass Graft
Prevalence of outliers ie patients lying completely outside the conventional risk stratification pts with 3 risk factors and no CAD at CTCA and pts with no risk factors and 5 coronary segments with CAD
Institutional Database will be used as data supply Data will be anonimyzed and pooled i twill not be possible to detect patients identity For this reason the investigators will no task for patients Informed Consent
DESIGN The investigators will retrospectively collect data from respective Institutional databases regarding patients who underwent CTCA for suspected CAD in the last 4 years
General Inclusion criteria Only patients with also Calcium Score
64-slice CT technology or 16-slice CT technology with 4 year follow-up Number of patients of at least 100 with complete clinical file and follow-up Minimum follow-up of 12 months Only patients with suspected Coronary Artery Disease
METHODS Study design and patient population This is an observational retrospective study consecutive patients meeting the inclusion criteria in patients with suspected coronary artery disease referred to our Institutions for evaluation by Computed Tomography Coronary Angiography CTCA starting in January 2003 Participating centers will provide data from 16-slice CTCA minimum follow-up 4 years or superior ie 64-slice CTCA minimum follow-up 12 months Each center will have to provide at least 200 patients with complete file for evaluation
Patients are usually referred because of symptoms chest pain dyspnoea on exertion andor abnormal or equivocal stress test andor high cardiovascular risk profile Exclusion criteria are renal failure creatinine clearance 60mlmin known previous reaction to iodinated contrast medium and pregnancy history of Myocardial Infarction previous revascularization PCI andor CABG
All the patients will be assessed by interview and by data collection from clinical database of the Institution for presence of cardiovascular risk factors and symptoms The following risk factors will be considered 1 Hypertension defined as Arterial Pressure 14080 mmHg or need for antihypertensive therapy 2 Hypercholesterolemia LDL Cholesterol 130 mgdl or current treatment with lipid-lowering therapy 3 Diabetes Mellitus current need for antidiabetic or insulin therapy 4 Smoking habit 5 Obesity Body Mass IndexBMI 30 6 Family history of cardiac disease Symptoms will be classified as no symptoms typical chest pain atypical chest pain dyspnoea on exertion The pre-test cardiovascular risk of the patients will be determined by means of the Morise risk score
Follow-up Follow-up data of all the patients were obtained by outpatient visit andor phone contact andor data collection from clinical database of the Institution Minimum follow-up will be 6 months Hospitalpatients records were screened for the occurrence of clinical events to confirm the obtained information The clinical end-points are 1 cardiac death 2 non-fatal acute myocardial infarction 3 unstable angina requiring hospitalization 4 percutaneous or surgical revascularization Cardiac death is defined as death caused by acute myocardial infarction or ventricular arrhythmias Non-fatal myocardial infarction is defined based on criteria of typical chest pain elevated cardiac enzyme levels and typical changes on the electrocardiogram Revascularization is defined as percutaneous coronary intervention PCI with stenting or coronary artery bypass surgery CABG The end point was the occurrence of one MACE at follow-up
Multislice computed tomography data acquisition All examinations were performed with a 16-slice or higher CT system Multi-vendor First a prospectively triggered coronary calcium CT data set was obtained using standardized CT parameters Thereafter CTCA was performed after the administration of a bolus 60-100ml non ionic contrast material Multi-vendor at flow rate of 4-6mls depending on patient status All injections were performed by power injector via an antecubital vein and were followed by 50 ml of saline bolus chase at the same flow rate A bolus tracking technique was used to determine the initiation of CT data acquisition CTCA was performed with the best available parameters depending on scanner type and generation The reconstruction slice thickness and increment were 05-075mm and 03-05mm respectively Intra-venous beta-blocker eg atenolol 5-10mg was administered to all patients with a heart rate 65 beatsmin and without contraindication known asthma or bronchospasm systolic blood pressure 100mmHg In addition nitro-glycerine was administered sublingually to all patients albeit contraindications known significant aortic stenosis systolic blood pressure 100mmHg Patients with atrial fibrillation or frequent premature beats were included in the study To obtain optimal image quality datasets were reconstructed at least at two points of the cardiac cycle using a retrospective ECG gating algorithm one diastolic cardiac phase usually at -350msec from the R waves and one end-systolic phase at 275msec In the presence of motion artefacts as in the case of cardiac arrhythmias additional reconstructions were made at different time points of the R-R interval At the time of the study tube current modulation was not used The estimated radiation dose would be 5-20mSv Axial data sets are transferred to a remote workstation Multi-vendor for post-processing and subsequent evaluation
CTCA data analysis - Coronary Artery Calcium Score The coronary artery calcium CACS score was assessed with the application of dedicated software Multi-vendor Coronary artery calcium was identified as a dense area in the coronary artery whose attenuation exceeded the threshold of 130 Hounsfield units HU The overall calcium score was calculated according to Agatston score algorithm for each patient
CTCA data analysis - Coronary Artery Atherosclerotic plaque assessment All CTCA angiograms are evaluated locally by 2 experienced board certified observers In case of disagreement a joint reading was performed and a consensus was reached Coronary arteries were divided into 15-16 segments according to the modified American Heart Association classification and in the case the intermediate branch was present it was added to the classification All coronary segments were considered in the analysis First each segment was classified as assessable or not assessable All assessable segments were then evaluated for the presence of any atherosclerotic plaque Axial images and curved multiplanar reconstructions of the segmental vasculature were utilized for the assessment Coronary plaques were defined as described previously as structures of 1mm2 within andor adjacent to the coronary artery lumen which are clearly distinguishable from the vessel lumen and surrounding pericardial tissue Obstructive coronary plaques were defined as plaques resulting in 50 luminal narrowing non obstructive plaques were defined as plaques that resulted in 50 luminal narrowing Patients were classified as belonging to one of three groups based on the CTCA findings 1 patients with normal coronary arteries 2 patients with non obstructive coronary artery disease and 3 patients with obstructive coronary artery disease presence of at least one plaque 50
Statistical analysis Categorical baseline characteristics expressed as numbers and percentages will be compared using the chi-square test Continuous variables expressed as mean and standard deviation SD will be compared using the 2-tailed t test and analysis of variance if normally distributed or by means of the Kruskal-Wallis method if not normally distributed A composite end-point of MACE will be used cardiac death non-fatal infarction unstable angina Cumulative event rates as a function of time were obtained by means of the Kaplan-Meier method Event curves of MACE will be compared using the log-rank test Cox regression analysis will be used to identify associations between clinical characteristics and CTCA variables and outcome Univariate and multivariate analyses will be performed to identify potential predictors In the multivariate analysis will be included only variables which were significant at univariate analysis Hazard ratios will be calculated with 95 confidence intervals as an estimate of the risk associated with a particular variable Statistical analyses will be performed using Excel 2007 software Microsoft United States MedCalc software version 80 United States STATA software version 10 United States SPSS software version 120 United States p values 005 will be considered statistically significant
Incremental value of CTCA above CACS will be analyzed Sub-analysis for the pre-test cardiovascular risk stratification according to the Morise score low-risk intermediate risk high risk will be performed
Sample size Based on our experience and data from literature the investigators estimated a sample size of 1000 patients Considering the retrospective nature of the study it is possible that at the end the investigators will reach a population 1000 patients which will anyway let the study continue to the expected 2 years duration
Primary objectives
MACEMajor Adverse Cardiovascular Events ie Cardiac Death Unstable Angina requiring Hospitalization Acute Myocardial Infarction
Prevalence of cardiovascular risk category shifting based on coronary plaque burden
Secondary objectives
Coronary Revascularizations occurred after CTCA ie PCIPercutaneous Coronary Revascularization and CABGCoronary Artery Bypass Graft
Prevalence of outliers ie patients lying completely outside the conventional risk stratification pts with 3 risk factors and no CAD at CTCA and pts with no risk factors and 5 coronary segments with CAD
Institutional Database will be used as data supply Data will be anonimyzed and pooled i twill not be possible to detect patients identity For this reason the investigators will no task for patients Informed Consent
DESIGN The investigators will retrospectively collect data from respective Institutional databases regarding patients who underwent CTCA for suspected CAD in the last 4 years
General Inclusion criteria Only patients with also Calcium Score
64-slice CT technology or 16-slice CT technology with 4 year follow-up Number of patients of at least 100 with complete clinical file and follow-up Minimum follow-up of 12 months Only patients with suspected Coronary Artery Disease
METHODS Study design and patient population This is an observational retrospective study consecutive patients meeting the inclusion criteria in patients with suspected coronary artery disease referred to our Institutions for evaluation by Computed Tomography Coronary Angiography CTCA starting in January 2003 Participating centers will provide data from 16-slice CTCA minimum follow-up 4 years or superior ie 64-slice CTCA minimum follow-up 12 months Each center will have to provide at least 200 patients with complete file for evaluation
Patients are usually referred because of symptoms chest pain dyspnoea on exertion andor abnormal or equivocal stress test andor high cardiovascular risk profile Exclusion criteria are renal failure creatinine clearance 60mlmin known previous reaction to iodinated contrast medium and pregnancy history of Myocardial Infarction previous revascularization PCI andor CABG
All the patients will be assessed by interview and by data collection from clinical database of the Institution for presence of cardiovascular risk factors and symptoms The following risk factors will be considered 1 Hypertension defined as Arterial Pressure 14080 mmHg or need for antihypertensive therapy 2 Hypercholesterolemia LDL Cholesterol 130 mgdl or current treatment with lipid-lowering therapy 3 Diabetes Mellitus current need for antidiabetic or insulin therapy 4 Smoking habit 5 Obesity Body Mass IndexBMI 30 6 Family history of cardiac disease Symptoms will be classified as no symptoms typical chest pain atypical chest pain dyspnoea on exertion The pre-test cardiovascular risk of the patients will be determined by means of the Morise risk score
Follow-up Follow-up data of all the patients were obtained by outpatient visit andor phone contact andor data collection from clinical database of the Institution Minimum follow-up will be 6 months Hospitalpatients records were screened for the occurrence of clinical events to confirm the obtained information The clinical end-points are 1 cardiac death 2 non-fatal acute myocardial infarction 3 unstable angina requiring hospitalization 4 percutaneous or surgical revascularization Cardiac death is defined as death caused by acute myocardial infarction or ventricular arrhythmias Non-fatal myocardial infarction is defined based on criteria of typical chest pain elevated cardiac enzyme levels and typical changes on the electrocardiogram Revascularization is defined as percutaneous coronary intervention PCI with stenting or coronary artery bypass surgery CABG The end point was the occurrence of one MACE at follow-up
Multislice computed tomography data acquisition All examinations were performed with a 16-slice or higher CT system Multi-vendor First a prospectively triggered coronary calcium CT data set was obtained using standardized CT parameters Thereafter CTCA was performed after the administration of a bolus 60-100ml non ionic contrast material Multi-vendor at flow rate of 4-6mls depending on patient status All injections were performed by power injector via an antecubital vein and were followed by 50 ml of saline bolus chase at the same flow rate A bolus tracking technique was used to determine the initiation of CT data acquisition CTCA was performed with the best available parameters depending on scanner type and generation The reconstruction slice thickness and increment were 05-075mm and 03-05mm respectively Intra-venous beta-blocker eg atenolol 5-10mg was administered to all patients with a heart rate 65 beatsmin and without contraindication known asthma or bronchospasm systolic blood pressure 100mmHg In addition nitro-glycerine was administered sublingually to all patients albeit contraindications known significant aortic stenosis systolic blood pressure 100mmHg Patients with atrial fibrillation or frequent premature beats were included in the study To obtain optimal image quality datasets were reconstructed at least at two points of the cardiac cycle using a retrospective ECG gating algorithm one diastolic cardiac phase usually at -350msec from the R waves and one end-systolic phase at 275msec In the presence of motion artefacts as in the case of cardiac arrhythmias additional reconstructions were made at different time points of the R-R interval At the time of the study tube current modulation was not used The estimated radiation dose would be 5-20mSv Axial data sets are transferred to a remote workstation Multi-vendor for post-processing and subsequent evaluation
CTCA data analysis - Coronary Artery Calcium Score The coronary artery calcium CACS score was assessed with the application of dedicated software Multi-vendor Coronary artery calcium was identified as a dense area in the coronary artery whose attenuation exceeded the threshold of 130 Hounsfield units HU The overall calcium score was calculated according to Agatston score algorithm for each patient
CTCA data analysis - Coronary Artery Atherosclerotic plaque assessment All CTCA angiograms are evaluated locally by 2 experienced board certified observers In case of disagreement a joint reading was performed and a consensus was reached Coronary arteries were divided into 15-16 segments according to the modified American Heart Association classification and in the case the intermediate branch was present it was added to the classification All coronary segments were considered in the analysis First each segment was classified as assessable or not assessable All assessable segments were then evaluated for the presence of any atherosclerotic plaque Axial images and curved multiplanar reconstructions of the segmental vasculature were utilized for the assessment Coronary plaques were defined as described previously as structures of 1mm2 within andor adjacent to the coronary artery lumen which are clearly distinguishable from the vessel lumen and surrounding pericardial tissue Obstructive coronary plaques were defined as plaques resulting in 50 luminal narrowing non obstructive plaques were defined as plaques that resulted in 50 luminal narrowing Patients were classified as belonging to one of three groups based on the CTCA findings 1 patients with normal coronary arteries 2 patients with non obstructive coronary artery disease and 3 patients with obstructive coronary artery disease presence of at least one plaque 50
Statistical analysis Categorical baseline characteristics expressed as numbers and percentages will be compared using the chi-square test Continuous variables expressed as mean and standard deviation SD will be compared using the 2-tailed t test and analysis of variance if normally distributed or by means of the Kruskal-Wallis method if not normally distributed A composite end-point of MACE will be used cardiac death non-fatal infarction unstable angina Cumulative event rates as a function of time were obtained by means of the Kaplan-Meier method Event curves of MACE will be compared using the log-rank test Cox regression analysis will be used to identify associations between clinical characteristics and CTCA variables and outcome Univariate and multivariate analyses will be performed to identify potential predictors In the multivariate analysis will be included only variables which were significant at univariate analysis Hazard ratios will be calculated with 95 confidence intervals as an estimate of the risk associated with a particular variable Statistical analyses will be performed using Excel 2007 software Microsoft United States MedCalc software version 80 United States STATA software version 10 United States SPSS software version 120 United States p values 005 will be considered statistically significant
Incremental value of CTCA above CACS will be analyzed Sub-analysis for the pre-test cardiovascular risk stratification according to the Morise score low-risk intermediate risk high risk will be performed
Sample size Based on our experience and data from literature the investigators estimated a sample size of 1000 patients Considering the retrospective nature of the study it is possible that at the end the investigators will reach a population 1000 patients which will anyway let the study continue to the expected 2 years duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None