Strain-Encoded Magnetic Resonance Imaging in Acute Myocar... | NCT00752713

Studies
Strain-Encoded Magnetic Resonance Imaging in Acute Myocardial Infarction

NCT00752713

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Sep 16, 2008Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

cardiac MRI

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

Sep 2008

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

Jan 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 11, 2008

First Submission Date that Met QC Criteria

Sep 12, 2008

First Posted Date

Sep 15, 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

Sep 15, 2008

Last Update Posted Date

Sep 16, 2008Estimated

Name	Class
Heidelberg University	OTHER

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 aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI).

Detailed Description

CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. Measurements were obtained for each segment in a modified 17 segment model. Wall motion and infarcted tissue were evaluated semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and MR-tagging was performed.

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients presenting to hospital with AMI	Procedure: cardiac MRI
2		healthy volunteers as control group	Procedure: cardiac MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac MRI	Procedure	cardiac MRI at one time point for group 1 after intervention for group 2 at any time point	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular function		01.01.2007 until 01.02.2007

Secondary Outcomes

Measure	Description	Time Frame
Transmurality		01.01.2007 until 01.02.2007

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with AMI after successful reperfusion
Healthy volunteers in control group

Exclusion Criteria:

No reperfusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive Patients with AMI 3+/-1 days after successful reperfusion
Ten healthy volunteers serving as control group

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirja Neizel, MD	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20846606	Derived	Neizel M, Korosoglou G, Lossnitzer D, Kuhl H, Hoffmann R, Ocklenburg C, Giannitsis E, Osman NF, Katus HA, Steen H. Impact of systolic and diastolic deformation indexes assessed by strain-encoded imaging to predict persistent severe myocardial dysfunction in patients after acute myocardial infarction at follow-up. J Am Coll Cardiol. 2010 Sep 21;56(13):1056-62. doi: 10.1016/j.jacc.2010.02.070.