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

NCT02184117 | Completed

• 1 other identifier: HSC-MS-14-0399
• Study Type: observational
• Target: 763
• Locations: 9 countries
• Sites: 11

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.

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve, Myocardial; Adenosine; Contrast Media

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Binary diagnostic performance

  Baseline

• Continuous relationship with FFR

  Baseline

Study Arms (1)

All patients

Entire cohort undergoes paired testing

Drug: Adenosine; Drug: Contrast Media; Drug: Resting conditions

Interventions

Adenosine DRUG

Intracoronary or intravenous adenosine to induce hyperemia for reference FFR

All patients

Contrast Media DRUG

Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"

All patients

Resting conditions DRUG

Baseline measurement of aortic and coronary pressures

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing FFR assessment for standard clinical indications

You may qualify if:

• Age 18 years or older.
• Undergoing FFR assessment for standard clinical indications.
• Ability to understand and willingness to sign a written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Abbott Medical Devices: collaborator

Study Sites (11)

Stanford University, Palo Alto VA

Palo Alto, California, 94304, United States

Location

Integris Health

Oklahoma City, Oklahoma, 73112, United States

Location

Cardiovascular Center (OLV-Ziekenhuis)

Aalst, Belgium

Location

Hôpital Louis Pradel

Lyon, France

Location

University of Naples Federico II

Naples, 80131, Italy

Location

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Hospital Fernando Fonseca

Lisbon, Portugal

Location

Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Södersjukhuset

Stockholm, Sweden

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

Related Publications (15)

• 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. doi: 10.1161/01.CIR.0000061950.24940.88. Epub 2003 Mar 31.

  PMID: 12668522 BACKGROUND

• 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 KG, Pijls NHJ, Fearon WF. Continuum of Vasodilator Stress From Rest to Contrast Medium to Adenosine Hyperemia for Fractional Flow Reserve Assessment. JACC Cardiovasc Interv. 2016 Apr 25;9(8):757-767. doi: 10.1016/j.jcin.2015.12.273.

  PMID: 27101902 RESULT

• Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.

  PMID: 37264699 DERIVED

• Johnson NP, Matsuo H, Nakayama M, Eftekhari A, Kakuta T, Tanaka N, Christiansen EH, Kirkeeide RL, Gould KL. Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1904-1913. doi: 10.1016/j.jcin.2021.07.041.

  PMID: 34503741 DERIVED

• Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001. No abstract available.

  PMID: 34503740 DERIVED

• Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.

  PMID: 30115688 DERIVED

• Johnson NP, Kirkeeide RL, Gould KL. Same Lesion, Different Artery, Different FFR!? JACC Cardiovasc Imaging. 2019 Apr;12(4):718-721. doi: 10.1016/j.jcmg.2017.11.029. Epub 2018 Jan 17. No abstract available.

  PMID: 29361484 DERIVED

• Kobayashi Y, Johnson NP, Zimmermann FM, Witt N, Berry C, Jeremias A, Koo BK, Esposito G, Rioufol G, Park SJ, Nishi T, Choi DH, Oldroyd KG, Barbato E, Pijls NHJ, De Bruyne B, Fearon WF; CONTRAST Study Investigators. Agreement of the Resting Distal to Aortic Coronary Pressure With the Instantaneous Wave-Free Ratio. J Am Coll Cardiol. 2017 Oct 24;70(17):2105-2113. doi: 10.1016/j.jacc.2017.08.049.

  PMID: 29050557 DERIVED

• Nishi T, Johnson NP, De Bruyne B, Berry C, Gould KL, Jeremias A, Oldroyd KG, Kobayashi Y, Choi DH, Pijls NHJ, Fearon WF; CONTRAST Study Investigators. Influence of Contrast Media Dose and Osmolality on the Diagnostic Performance of Contrast Fractional Flow Reserve. Circ Cardiovasc Interv. 2017 Oct;10(10):e004985. doi: 10.1161/CIRCINTERVENTIONS.117.004985.

  PMID: 29042397 DERIVED

• Matsumura M, Johnson NP, Fearon WF, Mintz GS, Stone GW, Oldroyd KG, De Bruyne B, Pijls NHJ, Maehara A, Jeremias A. Accuracy of Fractional Flow Reserve Measurements in Clinical Practice: Observations From a Core Laboratory Analysis. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1392-1401. doi: 10.1016/j.jcin.2017.03.031.

  PMID: 28728652 DERIVED

• Gargiulo G, Stabile E, Ferrone M, Barbato E, Zimmermann FM, Adjedj J, Hennigan B, Matsumura M, Johnson NP, Fearon WF, Jeremias A, Trimarco B, Esposito G; CONTRST Study Investigators. Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study. Cardiovasc Diabetol. 2017 Jan 13;16(1):7. doi: 10.1186/s12933-016-0494-2.

  PMID: 28086778 DERIVED

• Johnson NP, Gould KL, Di Carli MF, Taqueti VR. Invasive FFR and Noninvasive CFR in the Evaluation of Ischemia: What Is the Future? J Am Coll Cardiol. 2016 Jun 14;67(23):2772-2788. doi: 10.1016/j.jacc.2016.03.584.

  PMID: 27282899 DERIVED

• Gould KL, Johnson NP. Coronary Blood Flow After Acute MI: Alternative Truths. JACC Cardiovasc Interv. 2016 Mar 28;9(6):614-7. doi: 10.1016/j.jcin.2016.02.009. No abstract available.

  PMID: 27013162 DERIVED

• Gould KL, Johnson NP. Myocardial Bridges: Lessons in Clinical Coronary Pathophysiology. JACC Cardiovasc Imaging. 2015 Jun;8(6):705-9. doi: 10.1016/j.jcmg.2015.02.013. No abstract available.

  PMID: 26068287 DERIVED

• Gould KL, Johnson NP, Kaul S, Kirkeeide RL, Mintz GS, Rentrop KP, Sdringola S, Virmani R, Narula J. Patient selection for elective revascularization to reduce myocardial infarction and mortality: new lessons from randomized trials, coronary physiology, and statistics. Circ Cardiovasc Imaging. 2015 May;8(5):e003099. doi: 10.1161/CIRCIMAGING.114.003099. No abstract available.

  PMID: 25977304 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Adenosine; Contrast Media

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Nils P Johnson, MD, MS

  University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

• William F Fearon, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

IT (1); GB (1); US (2); BE (1); PT (1); NL (1); FR (1); KR (2); SE (1)