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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Adenosine; Drug: Contrast Media; Drug: Resting conditions

• Registration Number: NCT02184117
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 763

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Resting conditions	Entire cohort undergoes paired testing
All patients	Contrast Media	Entire cohort undergoes paired testing
All patients	Adenosine	Entire cohort undergoes paired testing

Primary Outcome Measures

Name	Time	Method
Agreement with binary FFR≤0.80	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

Name	Time	Method
Binary diagnostic performance	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	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).

Trial Locations

Locations (11)

Hôpital Louis Pradel; 🇫🇷 Lyon, France

Cardiovascular Center (OLV-Ziekenhuis); 🇧🇪 Aalst, Belgium

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

University of Naples Federico II; 🇮🇹 Naples, Italy

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Integris Health; 🇺🇸 Oklahoma City, Oklahoma, United States

Stanford University, Palo Alto VA; 🇺🇸 Palo Alto, California, United States

Hospital Fernando Fonseca; 🇵🇹 Lisbon, Portugal

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom