Myocardial InfarctionNCT00926133
Type 2 Diabetes and Acute Myocardial Infarction
An observational study of Myocardial Infarction and Type 2 Diabetes, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Type 2 Diabetes, Impaired Glucose Tolerance
- What is being tested?
- OGTT
- Type of treatment
- Pill or oral medicine
- How many people
- 224 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ST-elevation myocardial infarction without known type 2-diabetes.
Who may be able to join
- patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.
- Stable patients
Who cannot join
- known DM
- unstable patient
- signs of heart failure
- renal failure defined as creatinine >200 umol/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
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.
Read the 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:
- 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.
- Being tested
- OGTT
- Medical subject headings
- Myocardial Infarction, Diabetes Mellitus, Type 2, Glucose Intolerance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTTOther
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | Patients with acute STEMI treated by PCI without previously known type 2 diabetes. Receives: Other: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).
Measured: Three-months after an acute ST-elevation myocardial infarction (STEMI).
Secondary outcomes (3)
Validate the results of an OGTT performed early after myocardial infarction,
Measured: Repeating the test after three months.
Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.
Measured: Three months
Study the relationship between abnormal glucose regulation and prognosis after STEMI.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Geir O Andersen, MD, PhD, Study chair, Ullevaal University HospitalEva C Knudsen, MD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926133
- Sponsor's protocol ID
- HSØ-123
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19183453Helseth 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.
PubMed 31615411Knudsen 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.
PubMed 21801387Knudsen 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.
PubMed 21624046
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT00926133
- Acronym / sponsor ID
- HSØ-123
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | Other: OGTTPatients with acute STEMI treated by PCI without previously known type 2 diabetes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ST-elevation myocardial infarction without known type 2-diabetes.
Key inclusion criteria (2 listed)
- patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.
- Stable patients
Key exclusion criteria (4 listed)
- known DM
- unstable patient
- signs of heart failure
- renal failure defined as creatinine >200 umol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OGTTOral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up. | Other | STEMI patients |
Primary outcome
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).
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
- Results publication: PubMed 19183453Knudsen 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.
- Derived from this study: PubMed 31615411Helseth 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.
- Derived from this study: PubMed 21801387Knudsen 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.
- Derived from this study: PubMed 21624046Knudsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir O Andersen, MD, PhD study chair
Ullevaal University Hospital
Eva C Knudsen, MD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Type 2 Diabetes, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926133, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.