Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04052763
Status:
TERMINATED
Last Update Posted:
2019-09-27
First Post:
2019-08-06
Brief Title:
FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Ability of FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome Admitted in the Emergency Department With Chest Pain a Diagnostic Accuracy Prospective Study
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Slow enrolment during the COVID pandemics
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a monocentric observational single arm study with the aim to determinate the ability of FFR-CT to exclude or confirm the presence of hemodynamically significant coronary stenosis compared to coronary angiography in high-risk acute coronary syndrome patients
Detailed Description:
Study Design and Procedure
The present study is a single arm double blinded prospective trial Patients admitted to hospital with high-risk non-ST elevation acute coronary syndrome NSTE-ACS and who accept to participate to the study will undergo a coronary compute tomography CT angiography within 23 hours after diagnosis in order to have time to proceed to coronary angiography within the recommended window time of 24h After realization of the CT they will benefit from guidelines recommended treatment including a coronary angiography According to internal and international guidelines all efforts will be made to perform the coronary angiography within 24h of acute coronary syndrome ACS diagnosis
The coronary CT angiography procedure takes approximately 1-2h including logistical organization and patient transportation and all efforts will be made not to delay the coronary angiography compared to patients who would not participate in the study At the time of coronary angiography patients will be blinded from the CT results as well as the direct treating physician and interventional cardiologist realizing the procedure in order to avoid any influence in patients management The procedure will be done using a 256-slice multi-detector CT GE Healthcare Revolution CT Chicago Illinois USA Just before the examination as routinely done for this non-invasive test to allow for optimal coronary vasodilation and visualization oral Metoprolol 25-50mg will be administered if necessary to ensure a heart rate of 65 bpm or lower as well as one unique dose of sublingual nitroglycerine 400-800mg Parameters used for CT acquisition will be as following 100 Kilovoltage peak kVp550 milliamperes mA for body mass index BMI 25 high definition mode 100 kVp550 mA for BMI included between 25 and 30 120 kVp600 mA for BMI30 standard definition mode Off line an FFR-CT will be calculated with the data of the coronary CT angiography by blinded investigators in a central FFR-CT core laboratory HeartFlow Redwood City CA 94063 USA Hemodynamically significant lesion will be defined as lesion with an FFR-CT value of 080
During the invasive coronary angiography fractional flow reserve FFR will be measured in all lesions with a visual diameter stenosis 30 using the PressureWire X Guidewire Abbott Chicago Illinois USA with the following protocol first equalization of the pressure wire and the aortic pressure will be performed at the tip of the guide catheter prior to all measurements Second the pressure wire will then be advanced distal to the stenosis Third hyperemia will be obtained using intracoronary adenosine 150mcg for the right coronary artery and 200mcg for the left descending or the circumflex coronary arteries Fourth at the end of the procedure the absence of a drift will be confirmed after a pull-back of the pressure to the same location as the initial equalization Hemodynamically significant lesion will be defined as lesion with an FFR value of 080
Of note in case of coronary angiography showing no obstructive coronary disease and thus not offering satisfactory explanation for the myocardial injury patients will undergo cardiac magnetic resonance imaging CMRI to detect a potential alternative diagnosis myocarditis Takotsubo
Both invasive FFR and FFR derived from FFR-CT will be compared with invasive FFR as gold standard
Follow-up
Follow-up will be organized 1 month 7 days 6 months 14 days and 12 months 14 days after the acute coronary syndrome These visits will include a detailed history as well as physical examination and ECG During the second visit a transthoracic echocardiography will be performed and a treadmill exercise stress test will be performed during the third visit
Data and Statistical Analysis
Statistical analysis will be carried out using SPSS 240 software SPSS Inc Chicago Illinois and Stata 143 Comparisons of characteristics of patients will be performed using Chi-squared tests for qualitative variables and Students t or Mann-Whitney tests as appropriate Confidence intervals CI for proportions sensitivity specificity accuracy will be calculated using the Wilson Score method With the last iteration of the FFR-CT software the per-patient sensitivity and specificity were 86 95 CI 77 to 92 and 79 95 CI 72 to 84 In the recent VERDICT trial based on NSTEMI patients 12 had 3 vessel disease 23 2 vessel disease which included left main 34 1 vessel disease 30 nothing Thus out of 100 patients with 300 coronaries we expect 106 ie 364634 vessels with a stenosis Based on the FAMOUS NSTEMI trial 60 of invasive FFR measurements of these stenoses were significant Thus with a standard error of 005 and for a power of 80 204 patients will be required However some of the CT will not be suitable for analysis and some patients will have to be excluded Therefore we plan to include 250 patients Of note these number is also in line with the literature investigating the accuracy of FFR-CT versus FFR in patients with stable coronary artery disease
The present study is a single arm double blinded prospective trial Patients admitted to hospital with high-risk non-ST elevation acute coronary syndrome NSTE-ACS and who accept to participate to the study will undergo a coronary compute tomography CT angiography within 23 hours after diagnosis in order to have time to proceed to coronary angiography within the recommended window time of 24h After realization of the CT they will benefit from guidelines recommended treatment including a coronary angiography According to internal and international guidelines all efforts will be made to perform the coronary angiography within 24h of acute coronary syndrome ACS diagnosis
The coronary CT angiography procedure takes approximately 1-2h including logistical organization and patient transportation and all efforts will be made not to delay the coronary angiography compared to patients who would not participate in the study At the time of coronary angiography patients will be blinded from the CT results as well as the direct treating physician and interventional cardiologist realizing the procedure in order to avoid any influence in patients management The procedure will be done using a 256-slice multi-detector CT GE Healthcare Revolution CT Chicago Illinois USA Just before the examination as routinely done for this non-invasive test to allow for optimal coronary vasodilation and visualization oral Metoprolol 25-50mg will be administered if necessary to ensure a heart rate of 65 bpm or lower as well as one unique dose of sublingual nitroglycerine 400-800mg Parameters used for CT acquisition will be as following 100 Kilovoltage peak kVp550 milliamperes mA for body mass index BMI 25 high definition mode 100 kVp550 mA for BMI included between 25 and 30 120 kVp600 mA for BMI30 standard definition mode Off line an FFR-CT will be calculated with the data of the coronary CT angiography by blinded investigators in a central FFR-CT core laboratory HeartFlow Redwood City CA 94063 USA Hemodynamically significant lesion will be defined as lesion with an FFR-CT value of 080
During the invasive coronary angiography fractional flow reserve FFR will be measured in all lesions with a visual diameter stenosis 30 using the PressureWire X Guidewire Abbott Chicago Illinois USA with the following protocol first equalization of the pressure wire and the aortic pressure will be performed at the tip of the guide catheter prior to all measurements Second the pressure wire will then be advanced distal to the stenosis Third hyperemia will be obtained using intracoronary adenosine 150mcg for the right coronary artery and 200mcg for the left descending or the circumflex coronary arteries Fourth at the end of the procedure the absence of a drift will be confirmed after a pull-back of the pressure to the same location as the initial equalization Hemodynamically significant lesion will be defined as lesion with an FFR value of 080
Of note in case of coronary angiography showing no obstructive coronary disease and thus not offering satisfactory explanation for the myocardial injury patients will undergo cardiac magnetic resonance imaging CMRI to detect a potential alternative diagnosis myocarditis Takotsubo
Both invasive FFR and FFR derived from FFR-CT will be compared with invasive FFR as gold standard
Follow-up
Follow-up will be organized 1 month 7 days 6 months 14 days and 12 months 14 days after the acute coronary syndrome These visits will include a detailed history as well as physical examination and ECG During the second visit a transthoracic echocardiography will be performed and a treadmill exercise stress test will be performed during the third visit
Data and Statistical Analysis
Statistical analysis will be carried out using SPSS 240 software SPSS Inc Chicago Illinois and Stata 143 Comparisons of characteristics of patients will be performed using Chi-squared tests for qualitative variables and Students t or Mann-Whitney tests as appropriate Confidence intervals CI for proportions sensitivity specificity accuracy will be calculated using the Wilson Score method With the last iteration of the FFR-CT software the per-patient sensitivity and specificity were 86 95 CI 77 to 92 and 79 95 CI 72 to 84 In the recent VERDICT trial based on NSTEMI patients 12 had 3 vessel disease 23 2 vessel disease which included left main 34 1 vessel disease 30 nothing Thus out of 100 patients with 300 coronaries we expect 106 ie 364634 vessels with a stenosis Based on the FAMOUS NSTEMI trial 60 of invasive FFR measurements of these stenoses were significant Thus with a standard error of 005 and for a power of 80 204 patients will be required However some of the CT will not be suitable for analysis and some patients will have to be excluded Therefore we plan to include 250 patients Of note these number is also in line with the literature investigating the accuracy of FFR-CT versus FFR in patients with stable coronary artery disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None