Clinical trial NCT02250963: Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Complications of Care (& [Post Operative])
Keywords: Dobutamine Stress Echocardiography
Computed tomography coronary angiography
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: non-cardiac surgery patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries
timeFrame: 1 month
Secondary outcomes:
measure: Diagnostic accuracy of DES vs. CTCA in the prediction of the perioperative all cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.
timeFrame: 1 month
measure: Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.
timeFrame: 1 month
Other outcomes:
measure: Diagnostic accuracy of blood viscosity test in the prediction of the perioperative cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.
timeFrame: 1 month
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-Do
Study officials:
References:
citation: 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.
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. No abstract available.
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. doi: 10.1016/s0735-1097(00)00586-6.
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. doi: 10.1016/j.jacc.2004.03.049.
citation: Ahn JH, Jeong YH, Park Y, Kwak CH, Jang JY, Hwang JY, Hwang SJ, Koh JS, Kim KH, Kang MG, Park JR. Head-to-head comparison of prognostic accuracy in patients undergoing noncardiac surgery of dobutamine stress echocardiography versus computed tomography coronary angiography (PANDA trial): A prospective observational study. J Cardiovasc Comput Tomogr. 2020 Nov-Dec;14(6):471-477. doi: 10.1016/j.jcct.2020.02.001. Epub 2020 Feb 4.