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

January 28, 2021 updated by: Gyeongsang National University Hospital
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-Do
      • Jinju, Gyeongsangnam-Do, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

non-cardiac surgery patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
DSE
Patients, who underwent Dobutamine Stress Echocardiography (DSE)
CTCA
Computed tomography coronary angiography is going to perform with a 64-slice system (Brilliance 64, Philips Healthcare, Best, the Netherlands).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GNUH-PANDA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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