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Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00952224
First received: August 3, 2009
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  Purpose

In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. The aim of the present study is to determine the prognostic significance and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial infarction (STEMI).


Condition Intervention
ST-Elevation Myocardial Infarction
 Other: magnetic resonance imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute myocardial infarction patients
Patients undergoing primary percutaneous coronary intervention in ST-elevation myocardial infarction plus magnetic resonance imaging
 Other: magnetic resonance imaging
magnetic resonance imaging is used for prognosis assessment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cohort of patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention

Criteria

Inclusion Criteria:

  • ST-elevation myocardial infarction < 12 hours
  • primary percutaneous coronary intervention

Exclusion Criteria:

  • previous myocardial infarction
  • prior fibrinolysis
  • contraindications to CMR at study entry (such as implanted pacemakers, defibrillators, claustrophobia or metallic intracranial implants)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952224

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Ingo Eitel, MD University of Leipzig
Study Director: Holger Thiele, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00952224     History of Changes
Other Study ID Numbers: Leipzig MR 1
Study First Received: August 3, 2009
Last Updated: August 4, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
myocardial salvage
cardiovascular magnetic resonance
magnetic resonance imaging
myocardial infarction
prognosis

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