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

August 10, 2017 updated by: Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1748

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
        • Contact:
      • Tianjin, China
        • Not yet recruiting
        • General Hospital of Tianjin Medical University
        • Contact:
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Bin Lu, MD
        • Contact:
        • Sub-Investigator:
          • Yang Gao, MD
      • Beijing, Beijing, China
        • Recruiting
        • Xiehe Hospital
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTA+CTP
Diagnostic test: CTA CTP
CT Angiography myocardial CT Perfusion
CTA only
Diagnostic test: CTA
CT Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 90 days, 6 months, 12 months, 24 months and 36 months
death, myocardial infarction and unstable angina requiring hospitalization
90 days, 6 months, 12 months, 24 months and 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invasive coronary angiography and revascularization
Time Frame: 90 days, 6 months, 12 months, 24 months and 36 months
invasive coronary angiography and PCI or CABG
90 days, 6 months, 12 months, 24 months and 36 months
he incidence of a composite of major complications from cardiovascular procedures and testing
Time Frame: 90 days, 6 months, 12 months, 24 months and 36 months
stroke, bleeding, anaphylaxis, renal failure
90 days, 6 months, 12 months, 24 months and 36 months
Quality of Life
Time Frame: 90 days, 6 months, 12 months, 24 months and 36
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
90 days, 6 months, 12 months, 24 months and 36
total medical cost
Time Frame: 90 days and 3 years
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat
90 days and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Peking Union Medical College Hospital
Guangdong Provincial People's Hospital
Tianjin Medical University General Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Investigators

  • Principal Investigator: Bin Lu, MD, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIFuwaiHospital-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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