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Clinical Trials/NCT00846222
NCT00846222UnknownPhase 3

Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study

Assaf-Harofeh Medical Center2 sites in 1 country10 target enrollmentStarted: February 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
10
Locations
2
Primary Endpoint
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 88 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Recent myocardial infarction: 24 hours of start pain
  • •Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP < 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
  • •Candidate for immediate percutaneous reperfusion
  • •Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation

Exclusion Criteria

  • •Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
  • •Pregnant women
  • •Absence of maximal support care

Outcomes

Primary Outcomes

Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.

Time Frame: 30 days

Secondary Outcomes

  • Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment(30 days)

Investigators

Sponsor Class
Other Gov

Study Sites (2)

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