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OpenTrials
Completed

NCT Number: NCT00137098

Coronary Care Caffeine: Influence of Coffee on Heart Rate 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

Sponsors and collaborators

Lead sponsor

The Royal Bournemouth Hospital

Other

Registry information

Official study title

Influence of Coffee on Heart Rate Variability Post Myocardial Infarction

Important dates

Study start
2003
Study completion
2006
First posted
Aug 29, 2005
Registry last updated
Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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