We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome

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.
 
ClinicalTrials.gov Identifier: NCT00952224
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:
University of Leipzig

Tracking Information
First Submitted Date August 3, 2009
First Posted Date August 6, 2009
Last Update Posted Date August 6, 2009
Study Start Date November 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2009)
Major adverse cardiac events [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 4, 2009)
Mortality [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome
Official Title Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cohort of patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention
Condition ST-Elevation Myocardial Infarction
Intervention Other: magnetic resonance imaging
magnetic resonance imaging is used for prognosis assessment
Study Groups/Cohorts Acute myocardial infarction patients
Patients undergoing primary percutaneous coronary intervention in ST-elevation myocardial infarction plus magnetic resonance imaging
Intervention: Other: magnetic resonance imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 4, 2009)
267
Original Actual Enrollment Same as current
Actual Study Completion Date March 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00952224
Other Study ID Numbers Leipzig MR 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor University of Leipzig
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ingo Eitel, MD Heart Center Leipzig - University Hospital
Study Director: Holger Thiele, MD Heart Center Leipzig - University Hospital
PRS Account University of Leipzig
Verification Date August 2009