NCT00833313

Brief Summary

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

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

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

17 years

First QC Date

January 5, 2009

Last Update Submit

February 6, 2023

Conditions

Keywords

Atrial fibrillationGene expressionGenetic

Outcome Measures

Primary Outcomes (1)

  • Gene expression

    Immediate

Interventions

Atrial biopsyPROCEDURE

Biopsy of left atrial free wall and possibly left atrial appendage

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery

You may qualify if:

  • Age 20-99 years
  • Undergoing cardiac surgery

You may not qualify if:

  • Prior cardiac surgery
  • chest radiation
  • recent chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (2)

  • Sigurdsson MI, Saddic L, Heydarpour M, Chang TW, Shekar P, Aranki S, Couper GS, Shernan SK, Muehlschlegel JD, Body SC. Post-operative atrial fibrillation examined using whole-genome RNA sequencing in human left atrial tissue. BMC Med Genomics. 2017 May 2;10(1):25. doi: 10.1186/s12920-017-0270-5.

  • Sigurdsson MI, Saddic L, Heydarpour M, Chang TW, Shekar P, Aranki S, Couper GS, Shernan SK, Seidman JG, Body SC, Muehlschlegel JD. Allele-specific expression in the human heart and its application to postoperative atrial fibrillation and myocardial ischemia. Genome Med. 2016 Dec 6;8(1):127. doi: 10.1186/s13073-016-0381-1.

Biospecimen

Retention: SAMPLES WITH DNA

Atrial tissue sample

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jochen D Muehlschlegel, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen D Muehlschlegel, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2009

First Posted

February 2, 2009

Study Start

August 1, 2008

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations