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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137098
First Posted: August 29, 2005
Last Update Posted: October 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Royal Bournemouth Hospital
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00137098     History of Changes
Other Study ID Numbers: BDEC Caffeine
First Submitted: August 26, 2005
First Posted: August 29, 2005
Last Update Posted: October 5, 2009
Last Verified: October 2009

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