CMR Repeatability in STEMI | NCT01468662

Studies
CMR Repeatability in STEMI

NCT01468662

Sponsor

University of Bristol

Status

Completed

Last Update Posted

Oct 28, 2014Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

STEMI

Interventions

Not provided

Countries

United Kingdom

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

Oct 2014

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 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

Nov 7, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 9, 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

Oct 27, 2014

Last Update Posted Date

Oct 28, 2014Estimated

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 investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.

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

40Actual

Label	Type	Description	Intervention Names
STEMI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inter-observer, intra-observer and inter-scan variability and agreement		Between 2 scans

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant may enter study if ALL of the following apply

ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with >1 mm ST-segment elevation, or >2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and > 20 minutes of cardiac chest pain
Written informed consent

Exclusion Criteria:

Participant may not enter study if ANY of the following apply

Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
Known allergy to gadolinium
Chronic atrial fibrillation
Renal impairment with eGFR <30
Cardiogenic shock
Patients with special communication needs

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

ST segment elevation myocardial infarction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisa McAlindon, BMBS	University of Bristol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol Heart Institute		Bristol		BS2 8HW	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25333474	Derived	McAlindon EJ, Pufulete M, Harris JM, Lawton CB, Moon JC, Manghat N, Hamilton MC, Weale PJ, Bucciarelli-Ducci C. Measurement of myocardium at risk with cardiovascular MR: comparison of techniques for edema imaging. Radiology. 2015 Apr;275(1):61-70. doi: 10.1148/radiol.14131980. Epub 2014 Oct 21.

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases