Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Heart Failure Clinical Trial

— CABGGenomics  

Official title:

Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01258231
• Other study ID #: 2000P001639
• Secondary ID: 5R01HL098601
• Status: Recruiting
• Start date: August 2000
• Est. completion date: August 2030

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Other known NCT identifiers

• NCT00281164

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: August 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Undergoing heart surgery
• Willing to provide consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Department Texas Heart Institute at St. Luke's Episcopal Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI), Texas Heart Institute, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Kidney Injury using KDIGO criteria: albumin/creatinine ratio (>/= 300 mg/g) and eGRF (< 60 mL/min/1.73^2)	Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.	Day of procedure to post procedure day 7
Other	Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia after their cardiac surgery)	Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes.	Day of procedure to year 5
Other	Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)	Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports, cardiac enzyme values, progress notes, and cardiac catheterization reports.	Day of procedure to year 5
Other	Heart failure per NYHA class II, III, IV	This will be measured in accordance to New York Heart Association Guidelines.	Day of procedure to year 5
Other	Quality of Life Survey - The Kansas City Cardiomyopathy Questionnaire (KCCQShortForm)	A questionnaire to assess for heart failure	Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Other	Quality of Life Survey - The Seattle Angina Questionnaire (SAQShortForm)	A questionnaire to assess for angina	Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Other	Quality of Life Survey - 12-item short form health survey (SF12)	A questionnaire to assess for overall health	Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Primary	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