Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137098
Status:
COMPLETED
Last Update Posted:
2009-10-05
First Post:
2005-08-26
Brief Title:
Coronary Care Caffeine Influence of Coffee on Heart Rate Post Myocardial Infarction
Sponsor:
The Royal Bournemouth Hospital
Organization:
The Royal Bournemouth Hospital
Study Overview
Official Title:
Influence of Coffee on Heart Rate Variability Post Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None