Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Aarhus University Hospital

Oxford University Hospitals, John Radcliffe Hospital, UK

The Hospital for Sick Children

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01665365

First received: August 13, 2012

Last updated: NA

Last verified: August 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 13, 2012

Last Updated Date

August 13, 2012

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Major adverse cardiovascular events (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

MACE defined as all cause mortality, rehospitalization for heart failure, myocardial infarction, and stroke. Data are collected from Danish nationwide registries and medical records.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

LV-function and remodeling [ Time Frame: 5 years ] [ Designated as safety issue: No ]

LV-function and remodeling measured by echocardiography.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

Official Title ^ICMJE

Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

Brief Summary

The aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

ST-elevation Myocardial Infarction (STEMI)

Intervention ^ICMJE

Procedure: Remote ischemic perconditioning

Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.

Study Arm (s)

Experimental: 1. Remote ischemic perconditioning
Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention (intervention group).

Intervention: Procedure: Remote ischemic perconditioning
No Intervention: 2.
Primary percutaneous coronary intervention (control group).

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

251

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of > 0,1 mV in 2 or more contiguous leads, 18 years or older.

Exclusion Criteria:

left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01665365

Other Study ID Numbers ^ICMJE

30685

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Aarhus University Hospital
Oxford University Hospitals, John Radcliffe Hospital, UK
The Hospital for Sick Children

Investigators ^ICMJE

Principal Investigator:

Astrid D Sloth, MD

Department of Cardiology, Aarhus University Hospital, Skejby

Information Provided By

University of Aarhus

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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