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Right Ventricular Damage in Cardiovascular Magnetic Resonance

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT01359306
First received: May 20, 2011
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance.

The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Right Ventricular Damage in ST-Elevation Myocardial Infarction. Risk Stratification by Visualization of Wall Motion, Edema and Delayed Enhancement Cardiovascular Magnetic Resonance

Resource links provided by NLM:

MedlinePlus related topics: Edema Heart Attack
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Major Adverse Cardiac Event [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum for assessment of creatine kinase myocardial band


Enrollment: 524
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

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

524 consecutive patients with ST elevation myocardial infarction.

Criteria

Inclusion Criteria:

  • Onset of symptoms <12 h before angioplasty.
  • ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads.

Exclusion Criteria:

  • Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359306

Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Matthias Grothoff, 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):

Responsible Party: Matthias Grothoff MD, University Leipzig Heart Center
ClinicalTrials.gov Identifier: NCT01359306     History of Changes
Other Study ID Numbers: RV-Damage 1/2007
Study First Received: May 20, 2011
Last Updated: May 23, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
Acute myocardial infarction
Right ventricular infarction
Cardiovascular Magnetic Resonance
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 June 13, 2013