Acute Myocardial InfarctionNCT00845468
Coronary Flow Reserve and Glucometabolic State
An observational study of Acute Myocardial Infarction and Diabetes Mellitus, run by Medicinsk Forsknings Afdeling at 1 site in Denmark.
Trial summary
Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and patients with diabetes mellitus have a worse outcome following an acute myocardial infarction than non-diabetic patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Diabetes Mellitus, Prediabetes
- How many people
- 190 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Aug 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from a acute myocardial infarction
Who may be able to join
- Newly diagnosed first AMI based on characteristic clinical symptoms and/or electrocardiographic signs of AMI and Troponin T or I or CK-MB over diagnostic limits for AMI
- Referral for coronary arteriography based on the actual myocardial infarction
- Written informed consent
Who cannot join
- Previous myocardial infarction
- Asthma bronchiale
- 2 or/and 3 degree atrio-ventricular block and paced rhythm
- Mental state that makes the patient unavailable in attending the study
- Use of dipyridamol
- Sick Sinus Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Flow Velocity Reserve According to Glucometabolic State in Acute Myocardial Infarction; Relation to Ventricular Systolic and Diastolic Function
Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and patients with diabetes mellitus have a worse outcome following an acute myocardial infarction than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic threshold of diabetes mellitus is also associated with increased risk of death compared to patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in acute myocardial infarction is high, and approximately 70% of myocardial infarction patients have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance, leaving only 30% with normal glucose metabolism. The increased mortality among patients with acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may play an important role among others in endothelial dysfunction, infarct healing and overall left ventricle function. This raises the question, whether patients with acute myocardial infarction and abnormal glucose metabolism have increased frequency of micro- or macrovascular disease or both.
Coronary flow velocity reserve reflects the patency of the epicardial coronary artery in combination with vasodilator capacity of the microcirculation and may therefore offer a tool for assessment of macro- and microcirculation.
This study will focus on the relation between coronary flow velocity reserve estimated by transthoracal Doppler echocardiography and mortality, risk for heart failure and left ventricle function after acute myocardial infarction stratified according to glycometabolic state
- Conditions
- Acute Myocardial Infarction, Diabetes Mellitus, Prediabetes
- Keywords
- coronary flow reserve, diabetes mellitus, acute myocardial infarction, transthoracic echocardiography
- Medical subject headings
- Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2006
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicinsk Forsknings Afdeling
- Sponsor type
- University, hospital or other
- Investigators
- Brian B Løgstrup, MD, Principal investigator, Medicinsk Forsknings Afdeling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845468
- Sponsor's protocol ID
- 07-4-B368-A1392-22379
- Other IDs
- VF 20050103
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Logstrup BB, Hofsten DE, Christophersen TB, Moller JE, Botker HE, Pellikka PA, Egstrup K. Influence of abnormal glucose metabolism on coronary microvascular function after a recent myocardial infarction. JACC Cardiovasc Imaging. 2009 Oct;2(10):1159-66. doi: 10.1016/j.jcmg.2009.06.012.
PubMed 19833304
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Flow Velocity Reserve According to Glucometabolic State in Acute Myocardial Infarction; Relation to Ventricular Systolic and Diastolic Function
- ClinicalTrials.gov ID
- NCT00845468
- Acronym / sponsor ID
- 07-4-B368-A1392-22379
- Conditions
- Acute Myocardial Infarction, Diabetes Mellitus, Prediabetes
- Keywords
- coronary flow reserve, diabetes mellitus, acute myocardial infarction, transthoracic echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Medicinsk Forsknings AfdelingUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- First posted
- 18 Feb 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.
Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and patients with diabetes mellitus have a worse outcome following an acute myocardial infarction than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic threshold of diabetes mellitus is also associated with increased risk of death compared to patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in acute myocardial infarction is high, and approximately 70% of myocardial infarction patients have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance, leaving only 30% with normal glucose metabolism. The increased mortality among patients with acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may play an important role among others in endothelial dysfunction, infarct healing and overall left ventricle function. This raises the question, whether patients with acute myocardial infarction and abnormal glucose metabolism have increased frequency of micro- or macrovascular disease or both.
Coronary flow velocity reserve reflects the patency of the epicardial coronary artery in combination with vasodilator capacity of the microcirculation and may therefore offer a tool for assessment of macro- and microcirculation.
This study will focus on the relation between coronary flow velocity reserve estimated by transthoracal Doppler echocardiography and mortality, risk for heart failure and left ventricle function after acute myocardial infarction stratified according to glycometabolic state
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from a acute myocardial infarction
Key inclusion criteria (3 listed)
- Newly diagnosed first AMI based on characteristic clinical symptoms and/or electrocardiographic signs of AMI and Troponin T or I or CK-MB over diagnostic limits for AMI
- Referral for coronary arteriography based on the actual myocardial infarction
- Written informed consent
Key exclusion criteria (6 listed)
- Previous myocardial infarction
- Asthma bronchiale
- 2 or/and 3 degree atrio-ventricular block and paced rhythm
- Mental state that makes the patient unavailable in attending the study
- Use of dipyridamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Derived from this study: PubMed 19833304Logstrup BB, Hofsten DE, Christophersen TB, Moller JE, Botker HE, Pellikka PA, Egstrup K. Influence of abnormal glucose metabolism on coronary microvascular function after a recent myocardial infarction. JACC Cardiovasc Imaging. 2009 Oct;2(10):1159-66. doi: 10.1016/j.jcmg.2009.06.012.
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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.
Brian B Løgstrup, MD principal investigator
Medicinsk Forsknings Afdeling
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 Acute Myocardial Infarction and Diabetes Mellitus, run by Medicinsk Forsknings Afdeling at 1 site in Denmark.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Feb 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845468, which also lists 1 linked publication.
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 18 Feb 2009.