Reproducibility of Magnetic Resonance Myocardial Salvage... | NCT00794300

Studies
Reproducibility of Magnetic Resonance Myocardial Salvage Index

NCT00794300

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

second magnetic resonance imaging scan

Countries

Germany

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

Jun 2018

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

Nov 1, 2008Actual

Primary Completion Date

Nov 1, 2009Actual

Completion Date

May 1, 2010Actual

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Nov 19, 2008

First Posted Date

Nov 20, 2008Estimated

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

Jun 21, 2018

Last Update Posted Date

Jun 26, 2018Actual

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 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.

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

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute myocardial infarction patients			Device: second magnetic resonance imaging scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
second magnetic resonance imaging scan	Device		Acute myocardial infarction patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial salvage index reproducibility		2 days

Secondary Outcomes

Measure	Description	Time Frame
infarct size reproducibility		2 days
area at risk reproducibility		2 days
microvascular obstruction reproducibility

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ST-elevation myocardial infarction
Primary percutaneous coronary intervention

Exclusion Criteria:

Contraindications for magnetic resonance imaging

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

ST-elevation myocardial infarction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holger Thiele, MD	Heart Center Leipzig - University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig - Heart Center		Leipzig		04289	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21279689	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases