NCT01500369

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Dec 2010

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

4 years

First QC Date

December 22, 2011

Last Update Submit

July 2, 2013

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationremote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

  • Post op atrial fibrillation

    Assess the indicence of post operative atrial fibrillation

    7 days post cardiac surgery

Secondary Outcomes (1)

  • Stroke

    7 days

Study Arms (2)

remote ischemic conditiong

ACTIVE COMPARATOR

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.

Other: sphygmomanometer cuff inflations

Standard Care

PLACEBO COMPARATOR

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

Other: standard of care

Interventions

sphygmomanometer cuff inflationsOTHER

: 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.

remote ischemic conditiong
standard of careOTHER

Placebo Comparator

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • amir Lotfi, MD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Lotfi, MD

CONTACT

413 7934 4490amir.lotfi@bhs.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 28, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)