NCT03250455

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,748

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

August 10, 2017

Last Update Submit

August 10, 2017

Conditions

CT Perfusion

Outcome Measures

Primary Outcomes (1)

  • MACE

    death, myocardial infarction and unstable angina requiring hospitalization

    90 days, 6 months, 12 months, 24 months and 36 months

Secondary Outcomes (4)

  • invasive coronary angiography and revascularization

    90 days, 6 months, 12 months, 24 months and 36 months

  • he incidence of a composite of major complications from cardiovascular procedures and testing

    90 days, 6 months, 12 months, 24 months and 36 months

  • Quality of Life

    90 days, 6 months, 12 months, 24 months and 36

  • total medical cost

    90 days and 3 years

Study Arms (2)

CTA+CTP

Diagnostic Test: CTA CTP

CTA only

Diagnostic Test: CTA

Interventions

CTA CTPDIAGNOSTIC_TEST

CT Angiography myocardial CT Perfusion

CTA+CTP
CTADIAGNOSTIC_TEST

CT Angiography

CTA only

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by CTA were enrolled.

You may qualify if:

  • age ≥18 years.
  • stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Xiehe Hospital

Beijing, Beijing Municipality, China

RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

General hospital of tianjin medical university

Tianjin, China

NOT YET RECRUITING

Study Officials

  • Bin Lu, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Gao, MD

CONTACT

86-10-88328651gaoyang226@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of Radilogy

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

August 1, 2017

Primary Completion

November 1, 2020

Study Completion

December 31, 2020

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

CN(5)