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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Cardiology Research UBC
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
David Wood, MD, Interventional Cardiology Research
ClinicalTrials.gov Identifier:
NCT01065103
First received: February 8, 2010
Last updated: September 23, 2013
Last verified: September 2013
  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: 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:


Further study details as provided by Cardiology Research UBC:

Primary Outcome Measures:
  • FFR measurement [ Time Frame: Baseline and repeated at 4-6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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:

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

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Cardiogenic shock or severe (Killip III) congestive heart failure
  3. Hemodynamically significant ventricular arrhythmias
  4. Severe recurrent clinically significant ischemia following successful PCI of the IRA
  5. Thrombocytopenia (platelet count <100,000)
  6. Severe anemia (HgB <100 g/L)
  7. Major bleeding during hospitalization of the index STEMI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 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
Cardiology Research UBC
University of British Columbia
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.
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.

Responsible Party: David Wood, MD, Principal Investigator, Interventional Cardiology Research
ClinicalTrials.gov Identifier: NCT01065103     History of Changes
Other Study ID Numbers: H09-03435
Study First Received: February 8, 2010
Last Updated: September 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by Cardiology Research UBC:
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 August 20, 2014