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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03250455
Other study ID # CIFuwaiHospital-2
Secondary ID
Status Recruiting
Phase N/A
First received August 10, 2017
Last updated August 10, 2017
Start date August 2017
Est. completion date December 31, 2020

Study information

Verified date August 2017
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Yang Gao, MD
Phone 86-10-88328651
Email gaoyang226@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1748
Est. completion date December 31, 2020
Est. primary completion date November 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CTA CTP
CT Angiography myocardial CT Perfusion
CTA
CT Angiography

Locations

Country Name City State
China Fuwai Hospital Beijing Beijing
China Xiehe Hospital Beijing Beijing
China Guangdong General Hospital Guangzhou Guangdong
China Shanghai Sixth People's Hospital Shanghai
China General hospital of tianjin medical university Tianjin

Sponsors (5)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital Guangdong General Hospital, Peking Union Medical College Hospital, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACE death, myocardial infarction and unstable angina requiring hospitalization 90 days, 6 months, 12 months, 24 months and 36 months
Secondary invasive coronary angiography and revascularization invasive coronary angiography and PCI or CABG 90 days, 6 months, 12 months, 24 months and 36 months
Secondary 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
Secondary 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
Secondary total medical cost Assess and compare total medical cost for the two diagnostic testing arms by intention to treat 90 days and 3 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02056769 - CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage N/A