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

• Conditions: CT Perfusion
• Interventions: Diagnostic Test: CTA CTP; Diagnostic Test: CTA

• Registration Number: NCT03250455
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Last Update Submitted: 2017-08-10
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15
• Primary Completion: 2020-11
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1748

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CTA+CTP	CTA CTP	-
CTA only	CTA	-

Primary Outcome Measures

Name	Time	Method
MACE	90 days, 6 months, 12 months, 24 months and 36 months	death, myocardial infarction and unstable angina requiring hospitalization

Secondary Outcome Measures

Name	Time	Method
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
invasive coronary angiography and revascularization	90 days, 6 months, 12 months, 24 months and 36 months	invasive coronary angiography and PCI or CABG
total medical cost	90 days and 3 years	Assess and compare total medical cost for the two diagnostic testing arms by intention to treat

Trial Locations

Locations (5)

General hospital of tianjin medical university; 🇨🇳 Tianjin, China

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Xiehe Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China