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| Name | Class |
|---|---|
| Semmelweis University Heart and Vascular Center | OTHER |
| Emory University | OTHER |
| Johns Hopkins University | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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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.
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 CCTA+CTP 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 CCTA+CTP 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 and/or 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 1:1 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA Strategy | Experimental | CCTA will be performed with one of the latest generation scanners. A stenosis > 50% will be considered as significant from an anatomical point of view. For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density. ISR > 50% will be considered as significant from an anatomical point of view. For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded. For patients with positive CCTA results, additional stress CTP will be performed subsequently. If indicated, vasodilatation will be induced with i.v. adenosine injection or regadenoson. Static or dynamic CTP will be performed according to local practice and scanner technology available. For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion. |
|
| Standard of care Strategy | Active Comparator | Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integration of CCTA with stress CTP when indicated | Diagnostic Test | When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reclassification rate of CCTA in group B due to the addition of CTP | For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment). | 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Downstream non-invasive testing | Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization. | 1- and 2-years. |
| Downstream invasive testing |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for cardiac reason | Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason. | 1- and 2-years. |
| Unstable angina | Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2016:37,267-315). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Pontone, MD, PhD | Centro Cardiologico Monzino, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino IRCCS | Milan | MI | 20138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19007693 | Background | Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031. | |
| 20537493 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| OTHER |
| Vall d'Hebron Institute Research | OTHER |
| Humanitas Research Hospital IRCCS, Rozzano-Milan | OTHER |
| Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo | UNKNOWN |
| IRCCS San Raffaele | OTHER |
| Mayo Clinic | OTHER |
| Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano | UNKNOWN |
| A.O.U. Città della Salute e della Scienza - Molinette Hospital | OTHER |
Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B).
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| Standard of care approach | Diagnostic Test | (a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA. |
|
Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization. |
| 1- and 2-years. |
| Prevalence of obstructive CAD at ICA | Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA. | 1- and 2-years. |
| Revascularization | Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment). | 1- and 2-years. |
| Effective Dose | Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization. | 1- and 2-years. |
| Overall costs related to downstream diagnostic tests. | Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement. | 1- and 2-years. |
| 1- and 2-years. |
| Non-fatal myocardial infarction | Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018. Eur Heart J 2019:40,237-269). | 1- and 2-years. |
| Cardiac death | Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause). Unwitnessed death and death of unknown cause will be classified as cardiovascular death. | 1- and 2-years. |
| MACE (Major adverse cardiovascular events) | MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death. | 1- and 2-years. |
| Cost-effectiveness ratio | Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy. | 1- and 2-years. |
| Background |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |