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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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