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NCT Number: NCT00564824

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

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.

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Key information

Conditions

Coronary Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Myocardial Ischemia Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute, Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

About this study

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:

  • Patients will be invited for two endothelial function tests 1 week apart.
  • ECG, heart rate & blood pressure will be recorded at rest prior to each test.
  • 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.
  • Prior to and after the FMD, blood will be drawn to test caffeine levels, adiponectin, CBC, electrolytes, CRP and lipids.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

Caffeine 200 mg tablet

Placebo

Drug

Placebo pills

Primary outcomes

  1. Flow-mediated dilation (FMD) as surrogate of brachial artery endothelial function

    Time frame: 1-2 hours post caffeine (or placebo)

Secondary outcomes

  1. Markers of inflammation such as hs-CRP, Il6, homocysteine, serum caffeine level

    Time frame: 1-2 hours post caffeine or placebo

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 28, 2007
Registry last updated
Feb 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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