Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction

NCT ID: NCT00137098

Last Updated: 2009-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-01-31

Brief Summary

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Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial infarction) is a common cause of death. It is well documented that sudden cardiac death after a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is a measure of beat-to-beat changes in heart rate, with a greater variation associated with a "healthier" heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the effect of coffee or tea on HRV after MI.

Detailed Description

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120 post MI patients on CCU will be studied during the first week of admission. Patients will be categorised using the following criteria: Infarct size and site; PMH; Co-morbidities; Drugs; Regular caffeine ingestion.

Patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea during admission. HRV will be assessed by non-invasive Holter-monitoring on the fifth day. Salivary caffeine concentration will be assessed concurrently to assess compliance.

Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Caffeine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ST-segment elevation (trans-mural) MI; sinus rhythm.
* Age \< 80 years.

Exclusion Criteria

* Cardiogenic shock
* Nothing by Mouth (NBM)
* Caffeine intolerance
* Atrial fibrillation, temporary or permanent pacing
* Complete heart block, bundle branch block, severe left ventricular impairment, non-ST segment MI/acute coronary syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Bournemouth Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Tristan Richardson, Dr

Role: PRINCIPAL_INVESTIGATOR

Royal Bournemouth Hospital

Locations

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Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BDEC Caffeine

Identifier Type: -

Identifier Source: org_study_id

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