Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-31 @ 7:24 AM
Study NCT ID:
NCT00926133
Status:
UNKNOWN
Last Update Posted:
2009-06-23
First Post:
2009-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetes and Acute Myocardial Infarction
Sponsor:
Ullevaal University Hospital
Organization:
Study Overview
Official Title:
Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: