The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease

Coronary Disease Clinical Trial

Official title: The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects & in Patients With Ischemic Heart Disease

Status Completed

Clinical Trial Summary

Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects.

This effect might be attributed to caffeine, given that decaffeinated coffee (<2 mg of caffeine) was not associated with any change in endothelial performance.

In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects & in patients with proven ischemic heart disease.

Clinical Trial Description

Background:

Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects.

This effect might be attributed to caffeine, given that decaffeinated coffee (<2 mg of caffeine) was not associated with any change in endothelial performance.

In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects & in patients with proven ischemic heart disease.

Aim:

To evaluate the impact of 200 mg caffeine tablet intake (equivalent to 2 cups of coffee), compared to placebo on brachial endothelial function in healthy subjects & in patients with proven ischemic heart disease.

Methods:

1. Patients will be invited for two endothelial function tests 1 week apart.

2. ECG, heart rate & blood pressure will be recorded at rest prior to each test.

3. Following overnight fasting and discontinuation of all medications for ≥ 12 hours and absence of > 48 hour caffeine consumption, patients will receive 200 mg of caffeine tablets or placebo, in a double-blind, cross-over study design. An hour later the patient will undergo endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent, nitroglycerin (NTG)-mediated vasodilation will be assessed non-invasively in the brachial artery, using a high resolution (15 MHz) linear array ultrasound.

4. Prior to and after the FMD, blood will be drawn to test caffeine levels, adiponectin, CBC, electrolytes, CRP and lipids. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

• NCT number: NCT00564824
• Study type: Interventional
• Source: Sheba Medical Center
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Completion date: January 2010