Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery

Cardiac Complications of Care (& [Post Operative]) Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02250963
• Other study ID #: GNUH-PANDA-01
• Status: Terminated
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2021
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Elective surgery

2. Intermediate or high-risk noncardiac surgeries 1) intermediate risk surgery:

intrathoracic, intraperitoneal, orthopedic,head and neck, and prostate 2) high risk surgery: vascular

3. Revised cardiac risk index score =1 (more than one of the following criteria) 1) vascular surgery, intraperitoneal, intrathoracic surgery 2) history of ischemic heart disease 3) history of heart failure 4) history of cerebrovascular disease 5) diabetes with insulin treatment 6) chronic kidney disease (serum creatinine > 2.0 mg/dL)

Exclusion Criteria:

1. Need for emergency surgery

2. Active cardiac conditions 1) recent (within 1 month) myocardial infarction 2) acute decompensated heart failure 3) severe valvular disease 4) fatal cardiac arrhythmia 5) acute pulmonary embolism 6) acute myocarditis

3. Relative contraindications or immeasurable coronary stenosis of the CTCA

Related Conditions & MeSH terms

• Cardiac Complications of Care (& [Post Operative])

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Hospital	Jinju	Gyeongsangnam-Do

Sponsors (1)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Ahn JH, Park JR, Min JH, Sohn JT, Hwang SJ, Park Y, Koh JS, Jeong YH, Kwak CH, Hwang JY. Risk stratification using computed tomography coronary angiography in patients undergoing intermediate-risk noncardiac surgery. J Am Coll Cardiol. 2013 Feb 12;61(6):661-8. doi: 10.1016/j.jacc.2012.09.060. — View Citation

American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine; Society for Vascular Surgery, Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF. 2009 ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery. J Am Coll Cardiol. 2009 Nov 24;54(22):e13-e118. doi: 10.1016/j.jacc.2009.07.010. Review. Erratum in: J Am Coll Cardiol. 2012 Jun 12;59(24):2306. — View Citation

Das MK, Pellikka PA, Mahoney DW, Roger VL, Oh JK, McCully RB, Seward JB. Assessment of cardiac risk before nonvascular surgery: dobutamine stress echocardiography in 530 patients. J Am Coll Cardiol. 2000 May;35(6):1647-53. — View Citation

Labib SB, Goldstein M, Kinnunen PM, Schick EC. Cardiac events in patients with negative maximal versus negative submaximal dobutamine echocardiograms undergoing noncardiac surgery: importance of resting wall motion abnormalities. J Am Coll Cardiol. 2004 Jul 7;44(1):82-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic accuracy of blood viscosity test in the prediction of the perioperative cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.	preoperative blood viscosity test using BVD (blood viscosity dynamic) system	1 month
Primary	Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries	Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve.; Postoperative hard cardiac events were defined as cardiac death, non-fatal myocardial infarction.	1 month
Secondary	Diagnostic accuracy of DES vs. CTCA in the prediction of the perioperative all cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.	Perioperative all cardiovascular events were defined as cardiac death, non-fatal myocardial infarction, pulmonary edema, ventricular fibrillation, new onset atrial fibrillation with hemodynamic compromise, complete heart block, pulmonary embolism, and prophylactic revascularization.	1 month
Secondary	Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.	Incremental diagnostic accuracy changes with DES and/or CTCA compared to RCRI alone.; Incremental diagnostic accuracy includes the area under the curve comparison analysis, integrated discrimination improvement, and net reclassification improvement.	1 month