NCT00926133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

June 22, 2009

Last Update Submit

June 22, 2009

Conditions

Myocardial InfarctionType 2 DiabetesImpaired Glucose ToleranceInflammation

Outcome Measures

Primary Outcomes (1)

  • The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).

    Three-months after an acute ST-elevation myocardial infarction (STEMI).

Secondary Outcomes (3)

  • Validate the results of an OGTT performed early after myocardial infarction,

    Repeating the test after three months.

  • Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.

    Three months

  • Study the relationship between abnormal glucose regulation and prognosis after STEMI.

    Two years

Study Arms (1)

STEMI patients

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

Other: OGTT

Interventions

OGTTOTHER

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

STEMI patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.
  • Stable patients

You may not qualify if:

  • known DM
  • unstable patient
  • signs of heart failure
  • renal failure defined as creatinine \>200 umol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital Ulleval

Oslo, 0407, Norway

Location

Related Publications (4)

  • 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.

    PMID: 19183453RESULT

  • 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.

    PMID: 31615411DERIVED

  • 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.

    PMID: 21801387DERIVED

  • 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.

    PMID: 21624046DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Myocardial InfarctionDiabetes Mellitus, Type 2Glucose IntoleranceInflammation

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Geir O Andersen, MD, PhD

    Ullevaal University Hospital

    STUDY CHAIR

  • Eva C Knudsen, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

November 1, 2005

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

NO(1)