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

NCT ID: NCT00564824

Last Updated: 2010-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-01-31

Brief 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.

Detailed 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.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

CAD patients

Patients with prior history of coronary artery disease (CAD) (myocardial infarction, cerebrovascular accident, coronary angioplasty, S/p CABG operation) who will be given on the first day either caffeine of placebo tablet and 1-2 hours thereafter a brachial artery endothelial function testing (BRT) will be assessed for measuring the FMD. After 1 week the patients will come for a second BRT on placebo/caffeine tablets. If the patient received caffeine tablet the first BRT, he will be receiving placebo tablet the second week, however, if the patient received placebo the first BRT, a caffeine tablet will be given prior to the second BRT.

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DRUG

Caffeine 200 mg tablet

Placebo

Patients with prior history of coronary artery disease (CAD) (myocardial infarction, cerebrovascular accident, coronary angioplasty, S/p CABG operation) who will be given on the first day either caffeine of placebo tablet and 1-2 hours thereafter a brachial artery endothelial function testing (BRT) will be assessed for measuring the FMD. After 1 week the patients will come for a second BRT on placebo/caffeine tablets. If the patient received caffeine tablet the first BRT, he will be receiving placebo tablet the second week, however, if the patient received placebo the first BRT, a caffeine tablet will be given prior to the second BRT.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo pills

Interventions

Caffeine

Caffeine 200 mg tablet

Intervention Type: DRUG

Placebo

Placebo pills

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with documented ischemic heart disease
• Healthy subjects who are not heavy regular coffee drinkers

Exclusion Criteria

• Patients with unstable angina pectoris
• Patients with acute or chronic heart failure
• Patients with cardiac arrhythmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Heart Institute, Sheba Medical Center

Principal Investigators

Michael Shechter, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Heart Institute, Chaim Sheba Medical Center, Tel Aviv University

Guy Shalmon, RD

Role: STUDY_DIRECTOR

Tel Aviv University

Locations

Heart Institute, Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

SHEBA-07-4913-MS-CTIL

Identifier Type: -

Identifier Source: org_study_id