Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00846222
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Myocardial Infarction Complicated With Cardiogenic Shock
 Procedure: Hypothermia
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild theraputic hypothermia Procedure: Hypothermia
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846222

Locations
Israel
Assaf Harofeh MC
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Publications:

Responsible Party: Alex Blatt MD, Assaf Harofeh MC
ClinicalTrials.gov Identifier: NCT00846222     History of Changes
Other Study ID Numbers: 192/08
Study First Received: February 16, 2009
Last Updated: February 17, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Shock
Shock, Cardiogenic
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 26, 2012