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

This study has been completed.
Sponsor:
Information provided by:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00137098
First received: August 26, 2005
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Caffeine
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Coffee on Heart Rate Variability Post Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137098

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: Tristan Richardson, Dr Royal Bournemouth Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137098     History of Changes
Other Study ID Numbers: BDEC Caffeine
Study First Received: August 26, 2005
Last Updated: October 2, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Caffeine
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014