Acute Myocardial Infarction by Penetrating Cardiac Trauma | NCT01182064

Studies
Acute Myocardial Infarction by Penetrating Cardiac Trauma

NCT01182064

Sponsor

Universidad de Antioquia

Status

Completed

Last Update Posted

Aug 16, 2010Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

Colombia

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

Mar 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

Apr 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Aug 13, 2010

First Submission Date that Met QC Criteria

Aug 13, 2010

First Posted Date

Aug 16, 2010Estimated

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

Aug 13, 2010

Last Update Posted Date

Aug 16, 2010Estimated

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

Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their damage in the cardiac injury repair. The investigators objectives are to know the PAMI incidence, make an approximation to PAMI pathophysiology, and propose management strategies.

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non infarct
Posttraumatic acute myocardial infarct without coronary injury
Posttraumatic acute myocardial infarct with coronary injury

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posttraumatic acute myocardial infarct		2 days

Secondary Outcomes

Measure	Description	Time Frame
Posttraumatic acute myocardial infarct without coronary injury		10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart stab Injury

Exclusion Criteria:

Previous cardiac injuries, coronary artery disease with previous diagnostic, previous coronary angiography (for any indication)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The study included patients admitted to the emergency department of the San Vicente de Paul University Hospital with a penetrating stab cardiac injury without previous injuries

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos H Morales, MD, MSc	Antioquia University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Vicente de Paul Hospital		Medellín	Antioquia		Colombia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22743380	Derived	Castano W, Morales CH, Senior JM, Benjumea WY, Sanchez J. Relationship of echocardiographic and coronary angiographic findings in patients with acute myocardial infarction secondary to penetrating cardiac trauma. J Trauma Acute Care Surg. 2012 Jul;73(1):111-6. doi: 10.1097/TA.0b013e318256a0d8.

ID	Term
D009203	Myocardial Infarction
D006335	Heart Injuries

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