NCT01359306

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
Last Updated

May 24, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

May 20, 2011

Last Update Submit

May 23, 2011

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionRight ventricular infarctionCardiovascular Magnetic ResonancePrognosis

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Event

    30 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

524 consecutive patients with ST elevation myocardial infarction.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Grothoff M, Elpert C, Hoffmann J, Zachrau J, Lehmkuhl L, de Waha S, Desch S, Eitel I, Mende M, Thiele H, Gutberlet M. Right ventricular injury in ST-elevation myocardial infarction: risk stratification by visualization of wall motion, edema, and delayed-enhancement cardiac magnetic resonance. Circ Cardiovasc Imaging. 2012 Jan;5(1):60-8. doi: 10.1161/CIRCIMAGING.111.967810. Epub 2011 Nov 11.

    PMID: 22080332DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for assessment of creatine kinase myocardial band

Study Officials

  • Matthias Grothoff, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

February 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 24, 2011

Record last verified: 2011-05