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

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ClinicalTrials.gov Identifier: NCT00564824
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:
Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Coronary Disease Drug: Caffeine Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects & in Patients With Ischemic Heart Disease
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Caffeine
Caffeine 200 mg tablet

Experimental: 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.
Drug: Placebo
Placebo pills




Primary Outcome Measures :
  1. Flow-mediated dilation (FMD) as surrogate of brachial artery endothelial function [ Time Frame: 1-2 hours post caffeine (or placebo) ]

Secondary Outcome Measures :
  1. Markers of inflammation such as hs-CRP, Il6, homocysteine, serum caffeine level [ Time Frame: 1-2 hours post caffeine or placebo ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564824


Locations
Israel
Heart Institute, Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michael Shechter, MD, MA Heart Institute, Chaim Sheba Medical Center, Tel Aviv University
Study Director: Guy Shalmon, RD Tel Aviv University

Additional Information:
Responsible Party: Michael Shechter, MD, PI, Heart Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00564824     History of Changes
Other Study ID Numbers: SHEBA-07-4913-MS-CTIL
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010

Keywords provided by Sheba Medical Center:
coronary disease
atherosclerosis
endothelial function
caffeine
cerebrovascular disease
prevention

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents