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Heart; Dysfunction Postoperative, Cardiac SurgeryCABGGenomicsNCT01258231

Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Genetic Predisposition to Disease, run by Brigham and Women's Hospital at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate. Read more about this study

Who is it for?
Ages 20 to 90 years
How many people
4,000 participants
Where
3 sitesUnited States
Study dates
Aug 2000to Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients undergoing heart surgery

Who may be able to join

  • Undergoing heart surgery
  • Willing to provide consent

Who cannot join

  • Enrolled in a concurrent drug or device trial that precludes concurrent enrollment

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites, 1 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Completed

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9068

    Amanda A Fox, MD, 214-648-8018, amanda.fox@utsouthwestern.edu

    Amanda A Fox, MD

    Recruiting

  • Department Texas Heart Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77225

    Completed

Other trials in United States

About this study

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.

Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate.

Read the detailed description

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. In addition, we also examine blood and urine biomarkers (proteins).

Medical subject headings
Genetic Predisposition to Disease, Atrial Fibrillation, Myocardial Infarction, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01258231
Study groupRoleWhat they receive
Cardiac surgeryAdult patients undergoing cardiac surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)

    Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.

    Measured: Day of procedure to year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2010 (estimated)
  2. Study startAug 2000
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

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
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01258231
Sponsor's protocol ID
2000P001639
Other IDs
5R01HL098601
Acronym
CABGGenomics
Status last verified
Aug 2024
First submitted
9 Dec 2010
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Sigurdsson MI, Muehlschlegel JD, Fox AA, Heydarpour M, Lichtner P, Meitinger T, Collard CD, Shernan SK, Body SC. Genetic Variants Associated With Atrial Fibrillation and PR Interval Following Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015;29(3):605-10. doi: 10.1053/j.jvca.2014.10.028. Epub 2014 Nov 4.

    PubMed 26009287

  • Barnet CS, Liu X, Body SC, Collard CD, Shernan SK, Muehlschlegel JD, Jarolim P, Fox AA. Plasma corin decreases after coronary artery bypass graft surgery and is associated with postoperative heart failure: a pilot study. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):374-81. doi: 10.1053/j.jvca.2014.11.001. Epub 2014 Nov 11.

    PubMed 25649697

  • Fox AA, Pretorius M, Liu KY, Collard CD, Perry TE, Shernan SK, De Jager PL, Hafler DA, Herman DS, DePalma SR, Roden DM, Muehlschlegel JD, Donahue BS, Darbar D, Seidman JG, Body SC, Seidman CE. Genome-wide assessment for genetic variants associated with ventricular dysfunction after primary coronary artery bypass graft surgery. PLoS One. 2011;6(9):e24593. doi: 10.1371/journal.pone.0024593. Epub 2011 Sep 30.

    PubMed 21980348

  • Fox AA, Marcantonio ER, Collard CD, Thoma M, Perry TE, Shernan SK, Muehlschlegel JD, Body SC. Increased peak postoperative B-type natriuretic peptide predicts decreased longer-term physical function after primary coronary artery bypass graft surgery. Anesthesiology. 2011 Apr;114(4):807-16. doi: 10.1097/ALN.0b013e31820ef9c1.

    PubMed 21427536

  • Muehlschlegel JD, Liu KY, Perry TE, Fox AA, Collard CD, Shernan SK, Body SC; CABG Genomics Investigators. Chromosome 9p21 variant predicts mortality after coronary artery bypass graft surgery. Circulation. 2010 Sep 14;122(11 Suppl):S60-5. doi: 10.1161/CIRCULATIONAHA.109.924233.

    PubMed 20837927

  • Muehlschlegel JD, Perry TE, Liu KY, Fox AA, Collard CD, Shernan SK, Body SC. Heart-type fatty acid binding protein is an independent predictor of death and ventricular dysfunction after coronary artery bypass graft surgery. Anesth Analg. 2010 Nov;111(5):1101-9. doi: 10.1213/ANE.0b013e3181dd9516. Epub 2010 May 10.

    PubMed 20457766

  • Perry TE, Muehlschlegel JD, Liu KY, Fox AA, Collard CD, Shernan SK, Body SC; CABG Genomics Investigators. Plasma neutrophil gelatinase-associated lipocalin and acute postoperative kidney injury in adult cardiac surgical patients. Anesth Analg. 2010 Jun 1;110(6):1541-7. doi: 10.1213/ANE.0b013e3181da938e. Epub 2010 Apr 30.

    PubMed 20435938

  • Perry TE, Muehlschlegel JD, Liu KY, Fox AA, Collard CD, Body SC, Shernan SK; CABG Genomics Investigators. Preoperative C-reactive protein predicts long-term mortality and hospital length of stay after primary, nonemergent coronary artery bypass grafting. Anesthesiology. 2010 Mar;112(3):607-13. doi: 10.1097/ALN.0b013e3181cea3b5.

    PubMed 20179497

  • Garvin S, Muehlschlegel JD, Perry TE, Chen J, Liu KY, Fox AA, Collard CD, Aranki SF, Shernan SK, Body SC. Postoperative activity, but not preoperative activity, of antithrombin is associated with major adverse cardiac events after coronary artery bypass graft surgery. Anesth Analg. 2010 Oct;111(4):862-9. doi: 10.1213/ANE.0b013e3181b7908c. Epub 2009 Oct 9.

    PubMed 19820236

  • Perry TE, Muehlschlegel JD, Liu KY, Fox AA, Collard CD, Body SC, Shernan SK; CABG Genomics Investigators. C-Reactive protein gene variants are associated with postoperative C-reactive protein levels after coronary artery bypass surgery. BMC Med Genet. 2009 May 8;10:38. doi: 10.1186/1471-2350-10-38.

    PubMed 19426506

  • Muehlschlegel JD, Perry TE, Liu KY, Nascimben L, Fox AA, Collard CD, Avery EG, Aranki SF, D'Ambra MN, Shernan SK, Body SC; CABG Genomics Investigators. Troponin is superior to electrocardiogram and creatinine kinase MB for predicting clinically significant myocardial injury after coronary artery bypass grafting. Eur Heart J. 2009 Jul;30(13):1574-83. doi: 10.1093/eurheartj/ehp134. Epub 2009 Apr 30.

    PubMed 19406870

  • Body SC, Collard CD, Shernan SK, Fox AA, Liu KY, Ritchie MD, Perry TE, Muehlschlegel JD, Aranki S, Donahue BS, Pretorius M, Estrada JC, Ellinor PT, Newton-Cheh C, Seidman CE, Seidman JG, Herman DS, Lichtner P, Meitinger T, Pfeufer A, Kaab S, Brown NJ, Roden DM, Darbar D. Variation in the 4q25 chromosomal locus predicts atrial fibrillation after coronary artery bypass graft surgery. Circ Cardiovasc Genet. 2009 Oct;2(5):499-506. doi: 10.1161/CIRCGENETICS.109.849075. Epub 2009 Aug 2.

    PubMed 20031626

Questions about this trial

What is this clinical trial studying?

An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Genetic Predisposition to Disease, run by Brigham and Women's Hospital at 3 sites 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 1 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: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5) (time frame: Day of procedure to year 5). 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 NCT01258231, which also lists 12 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 22 Aug 2024.

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