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

NCT00564824 | Completed Phase 3

• 1 other identifier: SHEBA-07-4913-MS-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

coronary disease; atherosclerosis; endothelial function; caffeine; cerebrovascular disease; prevention

Outcome Measures

Primary Outcomes (1)

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

  1-2 hours post caffeine (or placebo)

Secondary Outcomes (1)

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

  1-2 hours post caffeine or placebo

Study Arms (2)

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

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

Interventions

Caffeine DRUG

Caffeine 200 mg tablet

CAD patients

Placebo DRUG

Placebo pills

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented ischemic heart disease
• Healthy subjects who are not heavy regular coffee drinkers

You may not qualify if:

• Patients with unstable angina pectoris
• Patients with acute or chronic heart failure
• Patients with cardiac arrhythmia

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Heart Institute, Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis; Cerebrovascular Disorders

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael Shechter, MD, MA

  Heart Institute, Chaim Sheba Medical Center, Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Guy Shalmon, RD

  Tel Aviv University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 25, 2010

Record last verified: 2010-02

Locations

IL (1)