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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Nils Johnson, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02184117
First received: July 2, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Drug: Adenosine
Drug: Contrast Media
Drug: Resting conditions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Agreement with binary FFR≤0.80 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.


Secondary Outcome Measures:
  • Binary diagnostic performance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Continuous relationship with FFR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 750
Study Start Date: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing FFR assessment for standard clinical indications

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02184117

Locations
Netherlands
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623EJ
United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom, G81 4HX
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
St. Jude Medical
Investigators
Principal Investigator: Nils P Johnson, MD, MS University of Texas Medical School at Houston
Study Director: William F Fearon, MD Stanford University
  More Information

Publications:
Responsible Party: Nils Johnson, Assistant Professor of Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02184117     History of Changes
Other Study ID Numbers: HSC-MS-14-0399
Study First Received: July 2, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Fractional Flow Reserve, Myocardial
Adenosine
Contrast Media

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Adenosine
Contrast Media
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Diagnostic Uses of Chemicals
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014