Type 2 Diabetes and Acute Myocardial Infarction

NCT ID: NCT00926133

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Myocardial Infarction; Type 2 Diabetes; Impaired Glucose Tolerance; Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI patients

Patients with acute STEMI treated by PCI without previously known type 2 diabetes.

OGTT

Intervention Type: OTHER

Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

Interventions

OGTT

Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ullevaal University Hospital

Principal Investigators

Geir O Andersen, MD, PhD

Role: STUDY_CHAIR

Ullevaal University Hospital

Eva C Knudsen, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

Oslo University Hospital Ulleval

Oslo, , Norway

Countries

Norway

References

Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Arnesen H, Andersen GO. Abnormal glucose regulation in patients with acute ST- elevation myocardial infarction-a cohort study on 224 patients. Cardiovasc Diabetol. 2009 Jan 30;8:6. doi: 10.1186/1475-2840-8-6.

Reference Type: RESULT

PMID: 19183453 (View on PubMed)

Helseth R, Knudsen EC, Eritsland J, Opstad TB, Arnesen H, Andersen GO, Seljeflot I. Glucose associated NETosis in patients with ST-elevation myocardial infarction: an observational study. BMC Cardiovasc Disord. 2019 Oct 15;19(1):221. doi: 10.1186/s12872-019-1205-1.

Reference Type: DERIVED

PMID: 31615411 (View on PubMed)

Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Muller C, Arnesen H, Andersen GO. Impact of newly diagnosed abnormal glucose regulation on long-term prognosis in low risk patients with ST-elevation myocardial infarction: A follow-up study. BMC Endocr Disord. 2011 Jul 29;11:14. doi: 10.1186/1472-6823-11-14.

Reference Type: DERIVED

PMID: 21801387 (View on PubMed)

Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Muller C, Arnesen H, Andersen GO. Elevated levels of PAI-1 activity and t-PA antigen are associated with newly diagnosed abnormal glucose regulation in patients with ST-elevation myocardial infarction. J Thromb Haemost. 2011 Aug;9(8):1468-74. doi: 10.1111/j.1538-7836.2011.04377.x.

Reference Type: DERIVED

PMID: 21624046 (View on PubMed)

Other Identifiers

HSØ-123

Identifier Type: -

Identifier Source: org_study_id