Overview

This trial is active, not recruiting.

Conditions myocardial infarction, type 2 diabetes, impaired glucose tolerance, inflammation
Treatment ogtt
Sponsor Ullevaal University Hospital
Start date November 2005
End date August 2009
Trial size 224 participants
Trial identifier NCT00926133, HSØ-123

Summary

The present study was designed to determine the prevalence of previously unknown impaired glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial infarction subjected to acute PCI. Secondary, a possible association between inflammation, haemostasis and abnormal glucose regulation was studied.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with acute STEMI treated by PCI without previously known type 2 diabetes.
ogtt
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

Primary Outcomes

Measure
The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).
time frame: Three-months after an acute ST-elevation myocardial infarction (STEMI).

Secondary Outcomes

Measure
Validate the results of an OGTT performed early after myocardial infarction,
time frame: Repeating the test after three months.
Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.
time frame: Three months
Study the relationship between abnormal glucose regulation and prognosis after STEMI.
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included. - Stable patients Exclusion Criteria: - known DM - unstable patient - signs of heart failure - renal failure defined as creatinine >200 umol/l

Additional Information

Official title Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
Principal investigator Eva C Knudsen, MD
Description Background: A high prevalence of impaired glucose tolerance (IGT) and unknown diabetes mellitus (DM) in patients with cardiovascular disease has been shown. European guidelines recommend screening of patients with AMI for DM and IGT by performing an oral glucose tolerance test (OGTT). The prevalence of IGT and DM in a Norwegian population of patients with AMI is unknown. Evidence are lacking regarding the reliability of an OGTT performed early after an AMI. The present study was designed to detect unknown IGT and DM in patients with AMI and the main challenge of the study was timing and reproducibility of the OGTT. In addition, mechanisms (inflammation, haemostasis) involved in impaired glucose regulation will be studied. Design: The study is designed as an observational cohort study prospectively including 200 patients with a primary PCI treated acute STEMI admitted to the coronary care unit at Ullevål university hospital. An OGTT is performed in-hospital and repeated after 3 months and a glucometabolic classification was performed according to the results. The patients will be followed for a minimum of two-years with regards to clinical endpoints. Aims of the study: 1. Study the prevalence of IGT and DM in a Norwegian population with acute STEMI. 2. Validate the results of an OGTT performed early after myocardial infarction, by repeating the test after three months. 3. Elucidate possible interactions between biomarkers of inflammation and coagulation, and the glucometabolic status. 4. Study the relationship between impaired glucose tolerance and prognosis after STEMI. 5. Contribute to an increased focus on undiagnosed DM and IGT in patients with coronary heart disease in Norway and the results may lead to an increased use of routine OGTT in the follow-up of patients with myocardial infarction. Investigate how patients with myocardial infarction and known glucometabolic state are followed up "in real-life" by their physicians. Clinical implications: The study may detect a large proportion of undetected DM and IGT in patients with AMI and change present guidelines on the follow-up of patients after AMI with increased focus on impaired glucose tolerance. The study will provide new insights about the association between inflammation, haemostasis and impaired glucose tolerance in patients with acute ST-elevation myocardial infarction.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.