CT Perfusion
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCTA CTP
CT Angiography myocardial CT Perfusion
DIAGNOSTIC_TESTCTA
CT Angiography
Sponsors
Peking Union Medical College Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Guangdong Provincial People's Hospital
Tianjin Medical University General Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. age ≥18 years. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 90 days, 6 months, 12 months, 24 months and 36 months | death, myocardial infarction and unstable angina requiring hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| invasive coronary angiography and revascularization | 90 days, 6 months, 12 months, 24 months and 36 months | invasive coronary angiography and PCI or CABG |
| he incidence of a composite of major complications from cardiovascular procedures and testing | 90 days, 6 months, 12 months, 24 months and 36 months | stroke, bleeding, anaphylaxis, renal failure |
| Quality of Life | 90 days, 6 months, 12 months, 24 months and 36 | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale |
| total medical cost | 90 days and 3 years | Assess and compare total medical cost for the two diagnostic testing arms by intention to treat |
Countries
China
Contacts
Primary ContactYang Gao, MD
Outcome results
None listed