Right Ventricular Damage in Cardiovascular Magnetic Reson... | NCT01359306

Studies
Right Ventricular Damage in Cardiovascular Magnetic Resonance

NCT01359306

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

May 24, 2011Estimated

Enrollment

524Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

May 20, 2011

First Submission Date that Met QC Criteria

May 23, 2011

First Posted Date

May 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2011

Last Update Posted Date

May 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

524Actual

Measure	Description	Time Frame
Major Adverse Cardiac Event		30 months

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

524 consecutive patients with ST elevation myocardial infarction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Grothoff, MD	Heart Center Leipzig - University Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22080332	Derived	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.