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NCT00137098 Clinical Trial

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

Myocardial Infarction Clinical Trial

Official title:
Influence of Coffee on Heart Rate Variability Post Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00137098
Other study ID # BDEC Caffeine
Secondary ID
Status Completed
Phase Phase 3
First received August 26, 2005
Last updated October 2, 2009
Start date September 2003
Est. completion date January 2006

Study information
Verified date October 2009
Source The Royal Bournemouth Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Caffeine

Locations
Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth Dorset

Sponsors (1)
Lead Sponsor Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

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