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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065103
First Posted: February 9, 2010
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
David Wood, MD, Cardiology Research UBC
  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: Intervention Model: Single Group Assignment
Masking: None (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 David Wood, MD, Cardiology Research UBC:

Primary Outcome Measures:
  • FFR measurement [ Time Frame: Baseline and repeated at 4-6 weeks ]

Enrollment: 48
Study Start Date: March 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065103


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
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. doi: 10.1016/j.jacc.2007.10.001. Review. 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. doi: 10.1016/j.jacc.2008.10.005.

Responsible Party: David Wood, MD, Principal Investigator, Cardiology Research UBC
ClinicalTrials.gov Identifier: NCT01065103     History of Changes
Other Study ID Numbers: H09-03435
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by David Wood, MD, 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
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs