Type 2 Diabetes and Acute Myocardial Infarction
|ClinicalTrials.gov Identifier: NCT00926133|
Recruitment Status : Unknown
Verified June 2009 by Ullevaal University Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
|Condition or disease||Intervention/treatment|
|Myocardial Infarction Type 2 Diabetes Impaired Glucose Tolerance Inflammation||Other: OGTT|
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:
- Study the prevalence of IGT and DM in a Norwegian population with acute STEMI.
- Validate the results of an OGTT performed early after myocardial infarction, by repeating the test after three months.
- Elucidate possible interactions between biomarkers of inflammation and coagulation, and the glucometabolic status.
- Study the relationship between impaired glucose tolerance and prognosis after STEMI.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.|
|Study Start Date :||November 2005|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||December 2009|
Patients with acute STEMI treated by PCI without previously known type 2 diabetes.
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.
- 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). ]
- 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 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926133
|Oslo University Hospital Ulleval|
|Oslo, Norway, 0407|
|Study Chair:||Geir O Andersen, MD, PhD||Ullevaal University Hospital|
|Principal Investigator:||Eva C Knudsen, MD||Ullevaal University Hospital|