Fractional Flow Reserve (FFR) Stability in Non-Culprit Vessels at ST Elevation Myocardial Infarction(STEMI) - Full Text View

Purpose

It has been shown that if it can be accomplished within a 90 minute "door to balloon" time, opening an artery in an acute heart attack situation (ST elevation myocardial infarction or STEMI) is best treated with balloon angioplasty and stenting (percutaneous coronary intervention or PCI). In these situations, there may be narrowings other than the one causing the heart attack (culprit) and studies have shown that delaying treatment of other narrowings for follow-up procedure is better than intervening at the time of the acute MI.

Condition	Intervention
Myocardial Infarction	Procedure: FFR (Fractional Flow Reserve)

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Fractional Flow Reserve Stability Study of Non-culprit Vessels in Patients With ST Elevation Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Further study details as provided by Interventional Cardiology Research:

Primary Outcome Measures:

FFR measurement [ Time Frame: Baseline and repeated at 4-8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	March 2010
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FFR measurement	Procedure: FFR (Fractional Flow Reserve) Single FFR measurement in non-culprit vessel

Show Detailed Description

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any patient >18 years of age with an acute STEMI eligible for primary PCI
Readily identifiable culprit vessel and at least one other (non-culprit) vessel of a least >50% severity by traditional angiography
Deemed appropriate for a strategy of delayed revascularization of the NCV.

Exclusion Criteria:

Inability to provide informed consent
Cardiogenic shock or severe (Killip III) congestive heart failure
Hemodynamically significant ventricular arrhythmias
Severe recurrent clinically significant ischemia following successful PCI of the IRA
Thrombocytopenia (platelet count <100,000)
Severe anemia (HgB <100 g/L)
Major bleeding during hospitalization of the index STEMI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065103

Contacts

Contact: David Wood, MD	604 875 5601	davewood34@hotmail.com
Contact: Andrew Starovoytov, MD	604 875 5079	a.starovoytov@ubc.ca

Locations

Canada, British Columbia
Vancouver General Hospital	Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Andrew Sytarovoytov, MD 604 875 5079 a.starovoytov@ubc.ca
Contact: Rebecca Fox, PA 604 875 4065 r.fox@telus.net
Sub-Investigator: Anthony Fung, MD
Sub-Investigator: Graham Wong, MD
Sub-Investigator: Jaap Hamburger, MD
Sub-Investigator: Jacqueline saw, MD
Sub-Investigator: John Mancini, MD
Sub-Investigator: John Cairns, MD
St. Paul's Hospital	Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Elizabeth Grieve, RN 604 682 2344 ext 62529 EGrieve@providencehealth.bc.ca
Sub-Investigator: Robert Boone, MD
Sub-Investigator: John Webb, MD
Sub-Investigator: Ronald Carere, MD
Sub-Investigator: Eve Aymong, MD

Sponsors and Collaborators

Interventional Cardiology Research

Investigators

Principal Investigator:

David Wood, MD

University of British Columbia

More Information

Publications:

Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. Review. No abstract available. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):977.

Keeley EC, Grines CL. Primary percutaneous coronary intervention for every patient with ST-segment elevation myocardial infarction: what stands in the way? Ann Intern Med. 2004 Aug 17;141(4):298-304. Review.

Keeley EC, Grines CL. Should patients with acute myocardial infraction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community? The case for emergency transfer for primary percutaneous coronary intervention. Circulation. 2005 Nov 29;112(22):3520-32; discussion 3533. No abstract available.

Koyama Y, Hansen PS, Hanratty CG, Nelson GI, Rasmussen HH. Prevalence of coronary occlusion and outcome of an immediate invasive strategy in suspected acute myocardial infarction with and without ST-segment elevation. Am J Cardiol. 2002 Sep 15;90(6):579-84.

Hanratty CG, Koyama Y, Rasmussen HH, Nelson GI, Hansen PS, Ward MR. Exaggeration of nonculprit stenosis severity during acute myocardial infarction: implications for immediate multivessel revascularization. J Am Coll Cardiol. 2002 Sep 4;40(5):911-6.

Goldstein JA, Demetriou D, Grines CL, Pica M, Shoukfeh M, O'Neill WW. Multiple complex coronary plaques in patients with acute myocardial infarction. N Engl J Med. 2000 Sep 28;343(13):915-22.

Corpus RA, House JA, Marso SP, Grantham JA, Huber KC Jr, Laster SB, Johnson WL, Daniels WC, Barth CW, Giorgi LV, Rutherford BD. Multivessel percutaneous coronary intervention in patients with multivessel disease and acute myocardial infarction. Am Heart J. 2004 Sep;148(3):493-500.

Glaser R, Selzer F, Faxon DP, Laskey WK, Cohen HA, Slater J, Detre KM, Wilensky RL. Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention. Circulation. 2005 Jan 18;111(2):143-9. Epub 2004 Dec 27.

Kong JA, Chou ET, Minutello RM, Wong SC, Hong MK. Safety of single versus multi-vessel angioplasty for patients with acute myocardial infarction and multi-vessel coronary artery disease: report from the New York State Angioplasty Registry. Coron Artery Dis. 2006 Feb;17(1):71-5.

Chen LY, Lennon RJ, Grantham JA, Berger PB, Mathew V, Singh M, Holmes DR Jr, Rihal CS. In-hospital and long-term outcomes of multivessel percutaneous coronary revascularization after acute myocardial infarction. Am J Cardiol. 2005 Feb 1;95(3):349-54.

Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; American College of Cardiology Foundation Appropriateness Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association for Thoracic Surgery; American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography; Heart Failure Society of America; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2009 Feb 10;53(6):530-53.

Lemesle G, de Labriolle A, Bonello L, Torguson R, Kaneshige K, Xue Z, Suddath WO, Satler LF, Kent KM, Lindsay J, Pichard AD, Waksman R. Incidence, predictors, and outcome of new, subsequent lesions treated with percutaneous coronary intervention in patients presenting with myocardial infarction. Am J Cardiol. 2009 May 1;103(9):1189-95. Epub 2009 Mar 13.

Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8.

De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. Circulation. 2001 Jul 10;104(2):157-62.

Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bär F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. Epub 2007 May 17.

Responsible Party:	David Wood, University of British Columbia
ClinicalTrials.gov Identifier:	NCT01065103 History of Changes
Other Study ID Numbers:	H09-03435
Study First Received:	February 8, 2010
Last Updated:	February 8, 2010
Health Authority:	Canada: Health Canada

Keywords provided by Interventional Cardiology Research:

STEMI
Primary angioplasty
Non-culprit vessel at STEMI

Fractional Flow Reserve
ST-elevation myocardial infarction
Fractional Flow Reserve in non-culprit vessel at STEMI

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013