Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

NCT ID: NCT01258231

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Heart; Dysfunction Postoperative, Cardiac Surgery Genetic Predisposition to Disease Atrial Fibrillation Myocardial Infarction Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery

Adult patients undergoing cardiac surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Undergoing heart surgery
* Willing to provide consent

Exclusion Criteria

* Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Texas Heart Institute

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jochen Daniel Muehlschlegel, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen D Muehlschlegel, MD MMSc, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status COMPLETED

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status COMPLETED

Countries

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United States

Facility Contacts

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Amanda A Fox, MD

Role: primary

214-648-8018

References

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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.

Reference Type BACKGROUND
PMID: 26009287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25649697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21980348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21427536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20837927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20457766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20435938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20179497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19820236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19426506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19406870 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20031626 (View on PubMed)

Other Identifiers

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5R01HL098601

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000P001639

Identifier Type: -

Identifier Source: org_study_id

NCT00281164

Identifier Type: -

Identifier Source: nct_alias

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