Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis

Study Overview
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Brief Summary
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VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.

Official Title
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Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis

Conditions
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CT Perfusion

Intervention / Treatment
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* Diagnostic Test: CTA CTP
* Diagnostic Test: CTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years. stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA. Exclusion Criteria: (1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB). (2) Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy. (3) Known CAD with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG). (4) Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms. (5) Contraindication to undergoing CTA, including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers, c. creatinine ≥1.7 mg/dl or GFR≤30 ml/min , d. Pregnancy. (6) Contraindication to ATP, including but not limited to: a. II or III atrioventricular block, b. bronchial asthma, c. hypotension (SBP<90mmHg), d. bronchial stenosis or bronchospasm, e. acute myocardial infarction, f. left main stenosis, g. unstable angina, h. allergy to aminophylline. (7) Life expectancy < 2 years. (8) Unable to provide written informed consent or participate in long-term follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTA+CTP<br> | Diagnostic Test: CTA CTP<br>* CT Angiography myocardial CT Perfusion<br>|
| CTA only<br> | Diagnostic Test: CTA<br>* CT Angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | death, myocardial infarction and unstable angina requiring hospitalization | 90 days, 6 months, 12 months, 24 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive coronary angiography and revascularization | invasive coronary angiography and PCI or CABG | 90 days, 6 months, 12 months, 24 months and 36 months | 
| he incidence of a composite of major complications from cardiovascular procedures and testing | stroke, bleeding, anaphylaxis, renal failure | 90 days, 6 months, 12 months, 24 months and 36 months | 
| Quality of Life | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 90 days, 6 months, 12 months, 24 months and 36 | 
| total medical cost | Assess and compare total medical cost for the two diagnostic testing arms by intention to treat | 90 days and 3 years |