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

Influence of Coffee on Heart Rate Variability Post Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Caffeine

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients of either gender, over 18 and under 80 years of age, admitted to the Coronary Care Unit following myocardial infarction.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: The Royal Bournemouth Hospital
• Investigators: Principal Investigator: Tristan Richardson, Dr, Royal Bournemouth Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (ACTUAL): January 1, 2006

Study Registration Dates

• First Submitted: August 26, 2005
• First Submitted That Met QC Criteria: August 26, 2005
• First Posted (ESTIMATE): August 29, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2009
• Last Update Submitted That Met QC Criteria: October 2, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: BDEC Caffeine