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

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ClinicalTrials.gov Identifier: NCT02184117
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : May 16, 2016
Abbott Medical Devices
Information provided by (Responsible Party):
Nils Johnson, The University of Texas Health Science Center, Houston

Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Drug: Adenosine Drug: Contrast Media Drug: Resting conditions

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.

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Study Type : Observational
Actual Enrollment : 763 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing FFR assessment for standard clinical indications

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184117

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United States, California
Stanford University, Palo Alto VA
Palo Alto, California, United States, 94304
United States, Oklahoma
Integris Health
Oklahoma City, Oklahoma, United States, 73112
Cardiovascular Center (OLV-Ziekenhuis)
Aalst, Belgium
Hôpital Louis Pradel
Lyon, France
University of Naples Federico II
Naples, Italy, 80131
Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623EJ
Hospital Fernando Fonseca
Lisbon, Portugal
Stockholm, Sweden
United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom, G81 4HX
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Abbott Medical Devices
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Principal Investigator: Nils P Johnson, MD, MS University of Texas Medical School at Houston
Study Director: William F Fearon, MD Stanford University
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nils Johnson, Associate Professor of Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02184117    
Other Study ID Numbers: HSC-MS-14-0399
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Nils Johnson, The University of Texas Health Science Center, Houston:
Fractional Flow Reserve, Myocardial
Contrast Media
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action