Recruiting
Phase 3

Remote Ischemic Preconditioning

Sponsor:

Baystate Medical Center

Code:

NCT01500369

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sphygmomanometer cuff inflations

standard of care

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT01500369

Start date

Dec, 2010

Status verified date

Jul, 2013

Completion date

Jun, 2015

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • any preoperative rhythm other than sinus,
  • history of atrial fibrillation,
  • New York Hear Association (NYHA) IV congestive heart failure,
  • cardiogenic shock,
  • emergent CABG and/or valve surgery,
  • bleeding diathesis, and
  • women of child-bearing potential. Eligible patients will participate after obtaining consent.

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: remote ischemic conditiong

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.

placebo comparator: Standard Care

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

Interventions

sphygmomanometer cuff inflations

: 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.

standard of care

Placebo Comparator

Primary outcome measure

  • Post op atrial fibrillation [ Time Frame: 7 days post cardiac surgery ]

Central Contacts and Locations

Central contacts

Amir Lotfi, MD

413 7934 4490amir.lotfi@bhs.org

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Amir Lotfi, MD

413-794-4490amir.lotfi@bhs.org

More Information

Sponsor

Baystate Medical Center

Last update posted

Jul 3, 2013

Last verified

Jul, 2013

Keywords

  • atrial fibrillation
  • remote ischemic conditioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2013-07-03.