Cardiac Complications of Care (& [Post Operative])NCT02250963
Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery
An observational study of Cardiac Complications of Care (& [Post Operative]), run by Gyeongsang National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Complications of Care (& [Post Operative])
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-cardiac surgery patients
Who may be able to join
- Elective surgery
- Intermediate or high-risk noncardiac surgeries 1) intermediate risk surgery: intrathoracic, intraperitoneal, orthopedic,head and neck, and prostate 2) high risk surgery: vascular
- 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)
Who cannot join
- Need for emergency surgery
- 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
- Relative contraindications or immeasurable coronary stenosis of the CTCA
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 660-702
About this study
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.
- Keywords
- Dobutamine Stress Echocardiography, Computed tomography coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac Complications of Care (& [Post Operative])Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250963
- Sponsor's protocol ID
- GNUH-PANDA-01
- Status last verified
- Jan 2021
- First submitted
- 15 Sep 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23391198American 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.
PubMed 19926002Das 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.
PubMed 10807472Labib 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.
PubMed 15234412Hendrianus H, Ahn JH, Kang MG, Kim KH, Koh JS, Kim SW, Hwang JY, Tantry US, Gurbel PA, Park JR, Jeong YH. Association of thrombogenicity indices with perioperative cardiovascular events after non-cardiac surgery: a prespecified analysis of the PANDA study. J Thromb Thrombolysis. 2026 Aug;59(6):1349-1361. doi: 10.1007/s11239-026-03299-z. Epub 2026 May 18.
PubMed 42149310Ahn 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.
PubMed 32057706
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT02250963
- Acronym / sponsor ID
- GNUH-PANDA-01
- Keywords
- Dobutamine Stress Echocardiography, Computed tomography coronary angiography
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-cardiac surgery patients
Key inclusion criteria (3 listed)
- Elective surgery
- Intermediate or high-risk noncardiac surgeries 1) intermediate risk surgery: intrathoracic, intraperitoneal, orthopedic,head and neck, and prostate 2) high risk surgery: vascular
- 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)
Key exclusion criteria (3 listed)
- Need for emergency surgery
- 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
- Relative contraindications or immeasurable coronary stenosis of the CTCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.
Time frame: 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 23391198Ahn 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.
- Background: PubMed 19926002American 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.
- Background: PubMed 10807472Das 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.
- Background: PubMed 15234412Labib 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.
- Derived from this study: PubMed 42149310Hendrianus H, Ahn JH, Kang MG, Kim KH, Koh JS, Kim SW, Hwang JY, Tantry US, Gurbel PA, Park JR, Jeong YH. Association of thrombogenicity indices with perioperative cardiovascular events after non-cardiac surgery: a prespecified analysis of the PANDA study. J Thromb Thrombolysis. 2026 Aug;59(6):1349-1361. doi: 10.1007/s11239-026-03299-z. Epub 2026 May 18.
- Derived from this study: PubMed 32057706Ahn 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Complications of Care (& [Post Operative]), run by Gyeongsang National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02250963, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.