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)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00125645
First received: July 29, 2005
Last updated: August 15, 2011
Last verified: April 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00125645

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

No publications provided

Responsible Party: Kenneth Egstrup Professor, department of Medicin
ClinicalTrials.gov Identifier: NCT00125645     History of Changes
Other Study ID Numbers: VF 20040053, 2612
Study First Received: July 29, 2005
Last Updated: August 15, 2011
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 01, 2014