Sudden cardiac death due to heart rhythm disturbance after heart attack(myocardial infarction)is a common cause of death. It is well documented that sudden cardiac death after 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 of sudden cardiac death is unknown. We aim to study the effect of coffee or tea on HRV after MI.

Condition	Intervention	Phase
Myocardial Infarction	Drug: Caffeine	Phase III

Further Study Details: 

Expected Total Enrollment:  120

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

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ST-segment elevation (trans-mural) MI, sinus rhythm, age <80 years.

Exclusion Criteria:

• Cardiogenic shock
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00137098

David Kerr, Dr      01202 704603    david.kerr@rbch.nhs.uk

United Kingdom, Dorset
      Royal Bournemouth Hospital, Bournemouth,  Dorset,  BH7 7DW,  United Kingdom; Recruiting

Study chairs or principal investigators

Tristan Richardson, Dr,  Principal Investigator,  Royal Bournemouth Hospital   

Study ID Numbers:  BDEC Caffeine
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00137098
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-30