Clinical trial NCT03250455: Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
Official title: Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CT Perfusion
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Guangdong Provincial People's Hospital
name: Tianjin Medical University General Hospital
First posted: 2017-08-15
Enrollment: 1748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by CTA were enrolled.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 90 days, 6 months, 12 months, 24 months and 36 months
Secondary outcomes:
measure: invasive coronary angiography and revascularization
timeFrame: 90 days, 6 months, 12 months, 24 months and 36 months
measure: he incidence of a composite of major complications from cardiovascular procedures and testing
timeFrame: 90 days, 6 months, 12 months, 24 months and 36 months
measure: Quality of Life
timeFrame: 90 days, 6 months, 12 months, 24 months and 36
measure: total medical cost
timeFrame: 90 days and 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Xiehe Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Tianjin
country: China
facility: General hospital of tianjin medical university
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Bin Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: