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

Coronary Artery Disease Clinical Trial

— CONTRAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184117
• Other study ID #: HSC-MS-14-0399
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: May 12, 2016
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Adenosine
Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
• Contrast Media
Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"
• Resting conditions
Baseline measurement of aortic and coronary pressures

Locations

Country	Name	City	State
Belgium	Cardiovascular Center (OLV-Ziekenhuis)	Aalst
France	Hôpital Louis Pradel	Lyon
Italy	University of Naples Federico II	Naples
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University College of Medicine	Seoul
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Portugal	Hospital Fernando Fonseca	Lisbon
Sweden	Södersjukhuset	Stockholm
United Kingdom	Golden Jubilee National Hospital	Clydebank
United States	Integris Health	Oklahoma City	Oklahoma
United States	Stanford University, Palo Alto VA	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	St. Jude Medical

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Korea, Republic of,  Netherlands,  Portugal,  Sweden,  United Kingdom, 

References & Publications (2)

De Bruyne B, Pijls NH, Barbato E, Bartunek J, Bech JW, Wijns W, Heyndrickx GR. Intracoronary and intravenous adenosine 5'-triphosphate, adenosine, papaverine, and contrast medium to assess fractional flow reserve in humans. Circulation. 2003 Apr 15;107(14):1877-83. Epub 2003 Mar 31. — View Citation

Johnson NP, Jeremias A, Zimmermann FM, Adjedj J, Witt N, Hennigan B, Koo BK, Maehara A, Matsumura M, Barbato E, Esposito G, Trimarco B, Rioufol G, Park SJ, Yang HM, Baptista SB, Chrysant GS, Leone AM, Berry C, De Bruyne B, Gould KL, Kirkeeide RL, Oldroyd — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement with binary FFR=0.80	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	No
Secondary	Binary diagnostic performance	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	No
Secondary	Continuous relationship with FFR	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	No