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remote ischemic conditiong for Atrial Fibrillation
Phase 3
Waitlist Available
Led By amir Lotfi, MD
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
This will be a prospective randomized controlled study on patients older than 18 years old who are undergoing elective CABG with or without valve surgery.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
Atrial fibrillation is the most common arrhythmic complication after coronary artery bypass grafting (CABG). Post operative atrial fibrillation (POAF) increases morbidity and mortality. Inflammation could be a factor in POAF and recent evidence of remotely inducing ischemia may reduce inflammation and cardiac injury. The investigators plan to use a blood pressure cuff on the arm as a method to produce remote ischemia and assess the occurrence of POAF for seven day.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post op atrial fibrillation
Secondary outcome measures
Stroke
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: remote ischemic conditiongActive Control1 Intervention
Patients in the treatment group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this "pre-conditioning" phase, routine anesthesia procedures will be implemented. The entire pre-conditioning phase will last 30 minutes.
Group II: Standard CarePlacebo Group1 Intervention
Patients in the control group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the treatment group, patients in the control group will undergo the same 30 minute delay before induction of anesthesia and surgery
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Who is running the clinical trial?
Baystate Medical CenterLead Sponsor
63 Previous Clinical Trials
43,863 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
25,060 Patients Enrolled for Atrial Fibrillation
amir Lotfi, MDPrincipal InvestigatorBaystate Medical Center
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