Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

NCT01258231 | Recruiting

• 2 other identifiers: 2000P0016395R01HL098601
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Day of procedure to year 5

Other Outcomes (7)

• Acute Kidney Injury using KDIGO criteria: albumin/creatinine ratio (>/= 300 mg/g) and eGRF (< 60 mL/min/1.73^2)

  Day of procedure to post procedure day 7

• Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia after their cardiac surgery)

  Day of procedure to year 5

• Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)

  Day of procedure to year 5

Study Arms (1)

Cardiac surgery

Adult patients undergoing cardiac surgery

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing heart surgery

You may qualify if:

• Undergoing heart surgery
• Willing to provide consent

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Texas Heart Institute: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

COMPLETED

UT Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

RECRUITING

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

Houston, Texas, 77225, United States

COMPLETED

Related Publications (12)

• 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.

  PMID: 26009287 BACKGROUND

• 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.

  PMID: 25649697 BACKGROUND

• 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.

  PMID: 21980348 BACKGROUND

• 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.

  PMID: 21427536 BACKGROUND

• 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.

  PMID: 20837927 BACKGROUND

• 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.

  PMID: 20457766 BACKGROUND

• 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.

  PMID: 20435938 BACKGROUND

• 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.

  PMID: 20179497 BACKGROUND

• 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.

  PMID: 19820236 BACKGROUND

• 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.

  PMID: 19426506 BACKGROUND

• 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.

  PMID: 19406870 BACKGROUND

• 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.

  PMID: 20031626 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, buffy coat, plasma, serum and urine

MeSH Terms

Conditions

Genetic Predisposition to Disease; Atrial Fibrillation; Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Jochen D Muehlschlegel, MD MMSc, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: August 1, 2000
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (3)