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

Terminated

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

• Registration Number: NCT02250963
• Lead Sponsor: Gyeongsang National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.	1 month	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.
Diagnostic accuracy of DES vs. CTCA in the prediction of the perioperative all cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.	1 month	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.

Trial Locations

Locations (1)

Gyeongsang National University Hospital; 🇰🇷 Jinju, Gyeongsangnam-Do, Korea, Republic of