Clinical trial NCT00564824: The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease
Official title: The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects & in Patients With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Disease
Keywords: coronary disease
atherosclerosis
endothelial function
caffeine
cerebrovascular disease
prevention
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Flow-mediated dilation (FMD) as surrogate of brachial artery endothelial function
timeFrame: 1-2 hours post caffeine (or placebo)
Secondary outcomes:
measure: Markers of inflammation such as hs-CRP, Il6, homocysteine, serum caffeine level
timeFrame: 1-2 hours post caffeine or placebo
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heart Institute, Chaim Sheba Medical Center
Study officials:
affiliation: Heart Institute, Chaim Sheba Medical Center, Tel Aviv University
name: Michael Shechter, MD, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Guy Shalmon, RD
role: STUDY_DIRECTOR
References: