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

NCT01665365 | Unknown DMC

• 1 other identifier: 30685
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-elevation Myocardial Infarction (STEMI)

Keywords

Myocardial infarction; Remote ischemic conditioning; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCE)

  MACCE defined as all-cause mortality, readmission for heart failure, myocardial infarction, and ischemic stroke/transient ischemic attack. Data are collected from Danish nationwide registries and medical records.

  5 years

Secondary Outcomes (1)

• LV-function and remodeling

  5 years

Study Arms (2)

1. Remote ischemic perconditioning

EXPERIMENTAL

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).

Procedure: Remote ischemic perconditioning

2.

NO INTERVENTION

Primary percutaneous coronary intervention (control group).

Interventions

Remote ischemic perconditioning PROCEDURE

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.

1. Remote ischemic perconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Astrid D Sloth, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: February 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2013-08

Locations

DK (1)