Protective Effect of Coronary Collaterals on Infarct Size... | NCT00412672

Studies
Protective Effect of Coronary Collaterals on Infarct Size in Patients With Acute Myocardial Infarction

NCT00412672

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Withdrawn

Last Update Posted

Jun 16, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

Not provided

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 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

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 15, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Name	Class
Swiss National Science Foundation	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 hypothesis of the current proposal is that collateral flow is an important determinant of myocardial protection during an ischemic event. Increased collateral flow for any given area at risk will decrease the myocardial damage caused by the occlusion of the infarct related epicardial artery.

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

Detailed Description

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

The two primary endpoints are infarct size as assessed by increase of biochemical cardiac markers and coronary collateral perfusion index (CPI) as obtained by transthoracic MCE.

Extent of LV remodelling, i.e., LV dilatation as assessed by serial assessment of LV dimension by LV angiogram and/or echocardiography, respectively.

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

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute myocardial infarction with electrocardiographic criterion and/or typical history of angina pectoris and planned revascularisation according to the acute myocardial infarction disease management guidelines of the University Hospital Bern. Including both, patients undergoing primary PCI and patients referred for rescue PCI after failed thrombolytic therapy
Patients > 18 years old of either sex
Patients who have given informed consent to the study

Exclusion Criteria:

Patients unable to give informed consent e.g. because of mechanical ventilation
Patients with cardiogenic shock
Patients with myocardial infarction secondary to occlusion of a recently revascularized vessel (subacute stent thrombosis)
Patients with severe arrhythmias
Patients whose door-to-balloon time exceeds 120 minutes
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with acute myocardial infarction undergoing primary PCI as reperfusion therapy of a totally occluded coronary artery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Seiler, Prof.	University Hospital Bern, Switzerland	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided