CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?) (CONTRAST)

May 12, 2016 updated by: Nils Johnson, The University of Texas Health Science Center, Houston
The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. While all these tests give a continuous result, we will apply binary cutoffs for comparison to FFR≤0.8 as the reference standard. Subjects will be selected prospectively from consecutive patients undergoing FFR assessment for standard clinical indications. The paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. To enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.

Study Type

Observational

Enrollment (Actual)

763

Contacts and Locations

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

Study Locations

  • Belgium
      • Aalst, Belgium
        • Cardiovascular Center (OLV-Ziekenhuis)
  • France
      • Lyon, France
        • Hôpital Louis Pradel
  • Italy
      • Naples, Italy, 80131
        • University of Naples Federico II
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University College of Medicine
  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
        • Catharina Hospital
  • Portugal
      • Lisbon, Portugal
        • Hospital Fernando Fonseca
  • Sweden
      • Stockholm, Sweden
        • Sodersjukhuset
  • United Kingdom
      • Clydebank, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University, Palo Alto VA
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Health

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing FFR assessment for standard clinical indications

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Undergoing FFR assessment for standard clinical indications.
  • Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

  • Prior coronary artery bypass grafting (CABG).
  • Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement.
  • Known severe left ventricular hypertrophy (septal wall thickness at echocardiography of >13 mm).
  • Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
  • Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
  • Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
  • Severe cardiomyopathy (ejection fraction <30%).
  • Renal insufficiency such that an additional 12 to 20 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.

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
All patients
Entire cohort undergoes paired testing
Drug: Adenosine
Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
Drug: Contrast Media
Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"
Drug: Resting conditions
Baseline measurement of aortic and coronary pressures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement with binary FFR≤0.80
Time Frame: Baseline
To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary diagnostic performance
Time Frame: Baseline
To describe the diagnostic performance of resting conditions and contrast medium injection using sensitivity and specificity, positive and negative predictive value, and area under the receiver operating characteristic (ROC) curve, compared to adenosine-derived FFR≤0.8 as the reference standard.
Baseline
Continuous relationship with FFR
Time Frame: Baseline
To determine the relationship between adenosine-derived FFR and either resting conditions or contrast medium injection using scatter plots (correlation coefficient) and Bland-Altman analysis (bias and limits of agreement).
Baseline

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Nils P Johnson, MD, MS, University of Texas Medical School at Houston
  • Study Director: William F Fearon, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-14-0399

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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