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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02250963

Enrollment

220

Registered

2014-09-26

Start date

2014-07-31

Completion date

2016-06-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Complications of Care (& [Post Operative])

Keywords

Dobutamine Stress Echocardiography, Computed tomography coronary angiography

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Other

Measure	Time frame	Description
Diagnostic accuracy of blood viscosity test in the prediction of the perioperative cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.	1 month	preoperative blood viscosity test using BVD (blood viscosity dynamic) system

Countries

South Korea

Outcome results