Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03976921
Status:
UNKNOWN
Last Update Posted:
2019-06-06
First Post:
2019-05-30
Brief Title:
Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease a Multicenter International Study
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_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:
CTP-PRO
Brief Summary:
CT myocardial perfusion imaging CTP represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making resource utilization and outcomes in a broad variety of geographic areas and patient subgroups
Detailed Description:
The use of cardiac computed tomography angiography CCTA is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure In the setting of intermediate to high risk patients the addition of functional information is prognostically useful and in patients with previous history of percutaneous coronary intervention PCI functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging CTP represents one of the newly developed CT-based techniques combining both anatomical and functional evaluation of CAD in a single imaging modality More recently stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTACTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making resource utilization and outcomes in a broad variety of geographic areas and patient subgroups
CTP-PRO study is a cooperative international multicentre prospective open-label randomized controlled study evaluating the cost-effectiveness of a CCTACTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation
Patients will be screened for study eligibility Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation then a structured interview will be performed and a clinical history obtained assessing the presence of common cardiac risk factors drug therapy focus on statin aspirin andor antiplatelet agent use and symptoms typical or atypical angina to estimate the pre-test likelihood of CAD
Upon completion of the screening procedure and enrollment the patients will be randomized 11 to the CT-based strategy Group A or usual care Group B Patient follow-up will be performed at 1 year 1 month and 2 years 1 month by trained interviewers who check medical records or by phone interview collecting the following information downstream testing overall radiation exposure outcomes cost-effectiveness estimation
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing prevalence of obstructive CAD at ICA revascularization cumulative ED and overall cost during the follow-up at 1- and 2-years The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years
CTP-PRO study is a cooperative international multicentre prospective open-label randomized controlled study evaluating the cost-effectiveness of a CCTACTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation
Patients will be screened for study eligibility Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation then a structured interview will be performed and a clinical history obtained assessing the presence of common cardiac risk factors drug therapy focus on statin aspirin andor antiplatelet agent use and symptoms typical or atypical angina to estimate the pre-test likelihood of CAD
Upon completion of the screening procedure and enrollment the patients will be randomized 11 to the CT-based strategy Group A or usual care Group B Patient follow-up will be performed at 1 year 1 month and 2 years 1 month by trained interviewers who check medical records or by phone interview collecting the following information downstream testing overall radiation exposure outcomes cost-effectiveness estimation
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing prevalence of obstructive CAD at ICA revascularization cumulative ED and overall cost during the follow-up at 1- and 2-years The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None