Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02773615
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2016-05-03
Brief Title:
CT Perfusion Added to CT Angiography
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
CT Perfusion Added to CT Angiography for Unstable Angina or Nonanginal Chest Pain in the Emergency Department PERFeCT a Feasibility and Safety Pilot Study
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
PERFeCT
Brief Summary:
Background In the differential diagnosis of unstable angina versus non-anginal chest pain an exercise test is often the modality of choice for further investigation However in a substantial number of patients exercise testing is less informative because of insufficient exercise capacity or pre-existing ECG-abnormalities In patients with low pretest probability of coronary artery disease CAD Coronary CT angiography CTA has an excellent negative predictive value but in patients with an intermediate or high pretest probability of CAD estimation of the hemodynamic significance of a stenosis has only limited specificity CT perfusion CTP is a new method looking at myocardial perfusion during vasodilative stress with a sensitivity specificity positive predictive value and negative predictive value of respectively 81 93 87 and 88 whereas radiation is limited to a maximum of 5 millisievert mSv
Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department
Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department
Detailed Description:
It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department
Methods Patients presenting in the emergency department with thoracic pain or other symptoms suggestive of angina will be eligible for the study if there are no ECG-signs of acute ischemia no STEMI or NSTEMI and if 2 serial high sensitivity Troponin T measurements with an interval of 1 hour are not conclusive for the diagnosis of ischemia
Exclusion criteria are a history of a STEMI or a NSTEMI with residual functional abnormalities atrial fibrillation renal insufficiency with glomerular filtration rate GFR 60 mlmin or known contrast allergy A number of 100 patients in one year is targeted
A pretest-probability score is calculated based on age gender and type of angina of the patient Typical angina is defined as substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest or nitrates within minutes atypical angina meets 2 of the 3 characteristics and nonanginal pain meets one or none of the characteristics The time point of admission in the emergency department is recordedcf Figure 1 Patients will undergo a CT Siemens Somatom Force with calcium-scoring and CT angiography CTA The amount of contrast used is about 60 ml and the radiation varies between 05 and 15 mSv If the CTA is completely normal and Ca-scoring is low 100 no further investigations are performed and the diagnosis of nonanginal pain is probable Patients are dismissed from the emergency ward with follow-up organized for one year Cf Figure 2
If there are abnormalities on CTA or if there is a elevated Ca-scoring 300 even in the absence of stenosis on CTA a CT perfusion sequence is added during dipyridamole stress The amount of contrast used for CTP is about 50 ml and the radiation used for CTP varies between 3 to 4 mSv resulting in a total radiation dose of less than 5 mSv Dipyridamole is administered in a dose of 140 µgkg body weightminute during 6 minutes through a peripheral vein CTP is performed 2 minutes after completion of the dipyridamole infusion
If CTP is suggestive of cardiac ischemia defined as a visual perfusion defect an invasive coronary angiography with fractional flow measurement if needed will be performed
If CTP is negative defined as no visual perfusion defect no further investigations are performed and the diagnosis of nonanginal pain is probable Patients are dismissed from the emergency ward with follow-up for one year Cf Figure 2
At dismissal patients are asked to fill in an angina-questionnaire short form Seattle Angina Questionnaire SAQ a quality of life SF-12 Health Survey and a satisfaction questionnaire about the hospital stay and investigational flow The time point of dismissal is recorded
After dismissal patients are contacted after 3 months to ask for hospitalizations or investigations that might have occurred in the mean time and to fill in the same SAQ and SF-12 At 12 months after the initial presentation patients are invited to a cardiac consultation and questionnaires are completed for the last time
Methods Patients presenting in the emergency department with thoracic pain or other symptoms suggestive of angina will be eligible for the study if there are no ECG-signs of acute ischemia no STEMI or NSTEMI and if 2 serial high sensitivity Troponin T measurements with an interval of 1 hour are not conclusive for the diagnosis of ischemia
Exclusion criteria are a history of a STEMI or a NSTEMI with residual functional abnormalities atrial fibrillation renal insufficiency with glomerular filtration rate GFR 60 mlmin or known contrast allergy A number of 100 patients in one year is targeted
A pretest-probability score is calculated based on age gender and type of angina of the patient Typical angina is defined as substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest or nitrates within minutes atypical angina meets 2 of the 3 characteristics and nonanginal pain meets one or none of the characteristics The time point of admission in the emergency department is recordedcf Figure 1 Patients will undergo a CT Siemens Somatom Force with calcium-scoring and CT angiography CTA The amount of contrast used is about 60 ml and the radiation varies between 05 and 15 mSv If the CTA is completely normal and Ca-scoring is low 100 no further investigations are performed and the diagnosis of nonanginal pain is probable Patients are dismissed from the emergency ward with follow-up organized for one year Cf Figure 2
If there are abnormalities on CTA or if there is a elevated Ca-scoring 300 even in the absence of stenosis on CTA a CT perfusion sequence is added during dipyridamole stress The amount of contrast used for CTP is about 50 ml and the radiation used for CTP varies between 3 to 4 mSv resulting in a total radiation dose of less than 5 mSv Dipyridamole is administered in a dose of 140 µgkg body weightminute during 6 minutes through a peripheral vein CTP is performed 2 minutes after completion of the dipyridamole infusion
If CTP is suggestive of cardiac ischemia defined as a visual perfusion defect an invasive coronary angiography with fractional flow measurement if needed will be performed
If CTP is negative defined as no visual perfusion defect no further investigations are performed and the diagnosis of nonanginal pain is probable Patients are dismissed from the emergency ward with follow-up for one year Cf Figure 2
At dismissal patients are asked to fill in an angina-questionnaire short form Seattle Angina Questionnaire SAQ a quality of life SF-12 Health Survey and a satisfaction questionnaire about the hospital stay and investigational flow The time point of dismissal is recorded
After dismissal patients are contacted after 3 months to ask for hospitalizations or investigations that might have occurred in the mean time and to fill in the same SAQ and SF-12 At 12 months after the initial presentation patients are invited to a cardiac consultation and questionnaires are completed for the last time
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