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

This study has suspended participant recruitment.
(Study terminated due to lack of patients)
Bristol-Myers Squibb
Information provided by:
University of Southern Denmark Identifier:
First received: July 29, 2005
Last updated: August 15, 2011
Last verified: April 2007
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 Intervention Phase
Myocardial Infarction Drug: irbesartan Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Southern Denmark:

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

Estimated Enrollment: 200
Study Start Date: March 2005
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00125645     History of Changes
Other Study ID Numbers: VF 20040053
Study First Received: July 29, 2005
Last Updated: August 15, 2011

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 processed this record on August 18, 2017