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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
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Nils Johnson, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date July 2, 2014
First Posted Date July 9, 2014
Last Update Posted Date May 16, 2016
Study Start Date July 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02184117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 2, 2014)
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
Official Title CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing FFR assessment for standard clinical indications
Condition Coronary Artery Disease
Intervention
  • 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
Study Groups/Cohorts All patients
Entire cohort undergoes paired testing
Interventions:
  • Drug: Adenosine
  • Drug: Contrast Media
  • Drug: Resting conditions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 12, 2016)
763
Original Estimated Enrollment
 (submitted: July 2, 2014)
750
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Italy,   Korea, Republic of,   Netherlands,   Portugal,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02184117
Other Study ID Numbers HSC-MS-14-0399
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nils Johnson, The University of Texas Health Science Center, Houston
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
PRS Account The University of Texas Health Science Center, Houston
Verification Date May 2016