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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring coronary disease, atherosclerosis, endothelial function, caffeine, cerebrovascular disease, prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Heart Institute, Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CAD patients

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2007
Last Updated
February 24, 2010
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00564824
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
coronary disease, atherosclerosis, endothelial function, caffeine, cerebrovascular disease, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAD patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Caffeine 200 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pills
Primary Outcome Measure Information:
Title
Flow-mediated dilation (FMD) as surrogate of brachial artery endothelial function
Time Frame
1-2 hours post caffeine (or placebo)
Secondary Outcome Measure Information:
Title
Markers of inflammation such as hs-CRP, Il6, homocysteine, serum caffeine level
Time Frame
1-2 hours post caffeine or placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shechter, MD, MA
Organizational Affiliation
Heart Institute, Chaim Sheba Medical Center, Tel Aviv University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy Shalmon, RD
Organizational Affiliation
Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Heart Institute, Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://www.heart.sheba.co.il
Description
The Heart Institute of the Sheba Medical Center and the Sackler Faculty of Medicine, Tel Aviv, Israel

Learn more about this trial

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

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