Status:
UNKNOWN
Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
CT Perfusion
Eligibility:
All Genders
18+ years
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 func...
Eligibility Criteria
Inclusion
- age ≥18 years.
- stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.
Exclusion
- (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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1748 Patients enrolled
Trial Details
Trial ID
NCT03250455
Start Date
August 1 2017
End Date
December 31 2020
Last Update
August 15 2017
Active Locations (5)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
2
Xiehe Hospital
Beijing, Beijing Municipality, China
3
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
4
Shanghai Sixth People's Hospital
Shanghai, China