Determination of the Prevalence and Prognostic Importance... | NCT00493168

Studies
Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI

NCT00493168

Sponsor

Duke University

Status

Completed

Last Update Posted

May 27, 2013Estimated

Enrollment

185Actual

Phase

Not provided

Conditions

Coronary Arteriosclerosis
Myocardial Infarction

Interventions

Not provided

Countries

United States

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 2007

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 1998

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 26, 2007

First Posted Date

Jun 28, 2007Estimated

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 24, 2013

Last Update Posted Date

May 27, 2013Estimated

Description Module

Brief Summary

The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.

Detailed Description

Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

185Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected coronary artery disease referred for invasive coronary angiography

Exclusion Criteria:

Clinical history of myocardial infarction
Percutaneous coronary intervention
Coronary artery bypass surgery
Known uncured malignancy
History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease
Contraindication of magnetic resonance imaging

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han W Kim, MD	Duke Cardiovascular Magnetic Resonance Center	Principal Investigator
Raymond J Kim, MD	Duke Cardiovascular Magnetic Resonance Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Medical School		Chicago	Illinois	60611	United States
Duke Cardiovascular Magnetic Resonance Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19381280	Derived	Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21.

ID	Term
D003324	Coronary Artery Disease
D009203	Myocardial Infarction

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases