Coronary Flow Reserve and Glucometabolic State

Diabetes Mellitus Clinical Trial

Official title:

Coronary Flow Velocity Reserve According to Glucometabolic State in Acute Myocardial Infarction; Relation to Ventricular Systolic and Diastolic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845468
• Other study ID #: 07-4-B368-A1392-22379
• Secondary ID: VF 20050103
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: February 17, 2009
• Start date: January 2006

Study information

• Verified date: February 2009
• Source: Medicinsk Forsknings Afdeling
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Regional Ethics Committee of Southern DenmarkDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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

2. Referral for coronary arteriography based on the actual myocardial infarction

3. Written informed consent

Exclusion Criteria:

1. Previous myocardial infarction

2. Asthma bronchiale

3. 2 or/and 3 degree atrio-ventricular block and paced rhythm

4. Mental state that makes the patient unavailable in attending the study

5. Use of dipyridamol

6. Sick Sinus Syndrome

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Diabetes Mellitus
• Infarction
• Myocardial Infarction
• Prediabetes

Locations

Country	Name	City	State
Denmark	Hospital of Fünen Svendborg	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Medicinsk Forsknings Afdeling

Country where clinical trial is conducted

Denmark,