Type 2 Diabetes and Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00926133
First received: June 22, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Myocardial Infarction
Type 2 Diabetes
Impaired Glucose Tolerance
Inflammation
Other: OGTT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validate the results of an OGTT performed early after myocardial infarction, [ Time Frame: Repeating the test after three months. ] [ Designated as safety issue: No ]
  • Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status. [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Study the relationship between abnormal glucose regulation and prognosis after STEMI. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples (serum,plasma) including PaxGene tubes for mRNA sampling


Enrollment: 224
Study Start Date: November 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
STEMI patients
Patients with acute STEMI treated by PCI without previously known type 2 diabetes.
Other: OGTT
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute ST-elevation myocardial infarction without known type 2-diabetes.

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
  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: NCT00926133

Locations
Norway
Oslo University Hospital Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Geir O Andersen, MD, PhD Oslo University Hospital Ulleval
Principal Investigator: Eva C Knudsen, MD Oslo University Hospital Ulleval
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geir Oystein Andersen, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00926133     History of Changes
Other Study ID Numbers: HSØ-123
Study First Received: June 22, 2009
Last Updated: June 22, 2009
Health Authority: Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Inflammation
Infarction
Diabetes Mellitus, Type 2
Myocardial Infarction
Glucose Intolerance
Diabetes Mellitus
Pathologic Processes
Ischemia
Necrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on September 16, 2014