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

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00564824

Purpose

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	Intervention	Phase
Coronary Disease	Drug: Caffeine Drug: Placebo	Phase III

MedlinePlus related topics: Caffeine Coronary Artery Disease Heart Diseases

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects & in Patients With Ischemic Heart Disease

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
CAD patients: Experimental 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
Placebo: Experimental 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

Arms

Assigned Interventions

CAD patients: Experimental

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

Placebo: Experimental

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

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:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564824

Contacts

Contact: Michael Shechter, MD, MA	+972-3-5302645	shechter@sheba.health.gov.il
Contact: Guy Shalmon, RD	+972523202401	guyshalmon@yahoo.com

Locations

Israel
Heart Institute, Chaim Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Michael Shechter, MD, MA
Sub-Investigator: Mickey Scheinowitz, PhD
Sub-Investigator: Pierre Chouraqui, MD
Sub-Investigator: Ben Ami Sela, PhD
Sub-Investigator: Yoni Sharabi, MD
Sub-Investigator: Hilel Halkin, MD
Sub-Investigator: Guy Shalmon, RD

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

More Information

The Heart Institute of the Sheba Medical Center and the Sackler Faculty of Medicine, Tel Aviv, Israel This link exits the ClinicalTrials.gov site

Study ID Numbers:	SHEBA-07-4913-MS-CTIL
Study First Received:	November 27, 2007
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00564824
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

coronary disease
atherosclerosis
endothelial function

caffeine
cerebrovascular disease
prevention

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Caffeine citrate
Heart Diseases
Myocardial Ischemia
Citric Acid
Vascular Diseases

Ischemia
Arteriosclerosis
Healthy
Cerebrovascular Disorders
Coronary Disease
Caffeine
Coronary Artery Disease

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants

Enzyme Inhibitors
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009