Atrial FibrillationNCT00833313
Gene Expression Profiling in Subjects With Postoperative Atrial Fibrillation After Cardiac Surgery (GENEXPRO Surg)
An observational study of Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery
Who may be able to join
- Age 20-99 years
- Undergoing cardiac surgery
Who cannot join
- Prior cardiac surgery
- chest radiation
- recent chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jochen D Muehlschlegel, MD, MMSc, 617-732-7330, jmuehlschlegel@bwh.harvard.edu
Jochen D Muehlschlegel, MD
About this study
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.
Read the detailed description
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.
This study seeks to identify regulatory events in atrial myocyte transcription and translation that are altered by germline variation
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial biopsy
- Keywords
- Atrial fibrillation, Gene expression, Genetic
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial biopsyProcedure or surgery
Biopsy of left atrial free wall and possibly left atrial appendage
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
- Investigators
- Jochen D Muehlschlegel, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833313
- Sponsor's protocol ID
- 2008-P000896
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2009
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28464817Sigurdsson 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.
PubMed 27923400
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling in Subjects With Postoperative Atrial Fibrillation After Cardiac Surgery (GENEXPRO Surg)
- ClinicalTrials.gov ID
- NCT00833313
- Acronym / sponsor ID
- 2008-P000896
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Gene expression, Genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This study seeks to identify regulatory events in atrial myocyte transcription and translation that are altered by germline variation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery
Key inclusion criteria (2 listed)
- Age 20-99 years
- Undergoing cardiac surgery
Key exclusion criteria (3 listed)
- Prior cardiac surgery
- chest radiation
- recent chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial biopsyBiopsy of left atrial free wall and possibly left atrial appendage | Procedure or surgery | – |
Primary outcome
Gene expression
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 28464817Sigurdsson 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.
- Results publication: PubMed 27923400Sigurdsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen D Muehlschlegel, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jochen D Muehlschlegel, MD (617-732-7330, jmuehlschlegel@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833313, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.