NCT00794300

Brief Summary

The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a rather new technique which can be used as a surrogate endpoint to reduce the sample size in studies comparing different reperfusion strategies in myocardial infarction. As reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20 patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

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

November 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

November 19, 2008

Last Update Submit

June 21, 2018

Conditions

Myocardial Infarction

Keywords

reproducibilitycontrast agentmagnetic resonance imaginginfarct sizemyocardial salvage indexmyocardial salvage assessment

Outcome Measures

Primary Outcomes (1)

  • Myocardial salvage index reproducibility

    2 days

Secondary Outcomes (3)

  • infarct size reproducibility

    2 days

  • area at risk reproducibility

    2 days

  • microvascular obstruction reproducibility

    2 days

Study Arms (1)

Acute myocardial infarction patients

Device: second magnetic resonance imaging scan

Interventions

second magnetic resonance imaging scanDEVICE
Acute myocardial infarction patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ST-elevation myocardial infarction

You may qualify if:

  • ST-elevation myocardial infarction
  • Primary percutaneous coronary intervention

You may not qualify if:

  • Contraindications for magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Related Publications (1)

  • Desch S, Engelhardt H, Meissner J, Eitel I, Sareban M, Fuernau G, de Waha S, Grothoff M, Gutberlet M, Schuler G, Thiele H. Reliability of myocardial salvage assessment by cardiac magnetic resonance imaging in acute reperfused myocardial infarction. Int J Cardiovasc Imaging. 2012 Feb;28(2):263-72. doi: 10.1007/s10554-011-9802-9. Epub 2011 Jan 30.

    PMID: 21279689DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

May 1, 2010

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

DE(1)