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Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00125645
Recruitment Status : Suspended (Study terminated due to lack of patients)
First Posted : August 1, 2005
Last Update Posted : August 16, 2011
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare changes in global left ventricular (LV) function after 3 months of treatment with irbesartan compared with usual care in patients with acute myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction. The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left ventricular function.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: irbesartan Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Global Left Ventricular Function After Acute Myocardial Infarction. Treatment With the Angiotensin 2-Receptor Blocker Irbesartan
Study Start Date : March 2005
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Irbesartan
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Left ventricular function [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented AMI; MPI > 0.55
  • Randomized within 7 days of AMI
  • Written informed consent

Exclusion Criteria:

  • Age < 18 years
  • Any contraindications to angiotensin 2-receptor blockade
  • In patients with WMSI > 1.3 treatment with ACE-inhibitor or angiotensin 2-receptor blockers
  • In patients with WMSI <= 1.3 no initiated or planned treatment with an ACE-inhibitor. Treatment with an ACE-inhibitor must be started within 7 days
  • Pregnancy or women of childbearing potential who are not using an effective method of contraception
  • Other comorbid conditions that could influence the study
  • Currently receiving an experimental study drug
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125645

Kardiologisk Klinik, Centralsygehuset Esbjerg/Varde
Esbjerg, Denmark, 6700
Sponsors and Collaborators
University of Southern Denmark
Bristol-Myers Squibb
Study Chair: Kenneth Egstrup, Asst. Professor Department of Medical Research, SHF Svendborg
More Information

Responsible Party: Kenneth Egstrup Professor, department of Medicin
ClinicalTrials.gov Identifier: NCT00125645     History of Changes
Other Study ID Numbers: VF 20040053
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: April 2007

Keywords provided by University of Southern Denmark:
Left ventricular function
Myocardial performance index
Acute myocardial infarction (AMI)

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angiotensin II
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents