Noncardiac SurgeryPREVENGE-CB-2NCT05812248
Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort Study
An observational study of Noncardiac Surgery, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This observational study includes patients at medium-to-high cardiovascular risks undergoing major noncardiac surgery, measures their baseline demographic and clinical characteristics, preoperative cardiac biomarkers and intraoperative surgery/anesthesia related data, and screens them for the occurrence of myocardial… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Noncardiac Surgery
- What is being tested?
- Perioperative cardiac biomarker measurement
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to Dec 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major noncardiac suregry with medium-to-high risks for postoperative cardiac complications.
Who may be able to join
- Age ≥ 45 years;
- Undergoing major noncardiac surgery (expected procedure duration ≥2 h, expected length of postoperative stay ≥2 d);
- History of at least one cardiovascular disease (i.e., coronary artery disease, stroke, congestive heart failure, or peripheral arterial disease) or with at least two cardiovascular risk factors (i.e., hypertension, diabetes, chronic kidney disease, smoking in the past ≥2 years, ≥65 years of age, hypercholesterolemia, history of TIA, high-risk surgery (intrathoracic, intraperitoneal, or major vascular)).
Who cannot join
- History of acute cardiovascular events within 30 days prior to surgery;
- American Society of Anesthesiologists (ASA) physical status of 5 or greater;
- Previously enrolled in this study;
- Unable to understand or to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Bingcheng Zhao, MD, 86-13763313653, zhaobch@mail2.sysu.edu.cn
About this study
This observational study includes patients at medium-to-high cardiovascular risks undergoing major noncardiac surgery, measures their baseline demographic and clinical characteristics, preoperative cardiac biomarkers and intraoperative surgery/anesthesia related data, and screens them for the occurrence of myocardial injury and major adverse cardiac events after surgery. The primary aim is to develop and validate a pre- and an immediate postoperative prediction model for occurrence of major adverse cardiac events.
- Conditions
- Noncardiac Surgery
- Being tested
- Perioperative cardiac biomarker measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative cardiac biomarker measurementDiagnostic test
High-sensitivity cardiac troponin T is measured within 7 days prior to surgery and at day 1 and day 2 after surgery. N-terminal pro-B-type natriuretic peptide is measured within 7 days before surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major adverse cardiac event
A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.
Measured: Within 30 days after the index surgery
Secondary outcomes (1)
Number of patients with myocardial injury after noncardiac suregry (MINS)
MINS is defined as a postoperative hsTnT level of 20 to less than 65 ng/L with an absolute change of at least 5 ng/L or a postoperative hsTnT level of at least 65 ng/L. A 20% or greater increase of hsTnT level from preoperative baseline is required to exclude chronic troponin elevation. Troponin elevations believed to be consequent to nonischemic causes are excluded.
Measured: Within 30 days after the index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jul 2022
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812248
- Sponsor's protocol ID
- NFEC-2022-223
- Acronym
- PREVENGE-CB-2
- Status last verified
- Sep 2024
- First submitted
- 2 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05812248
- Acronym / sponsor ID
- PREVENGE-CB-2 / NFEC-2022-223
- Conditions
- Noncardiac Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Apr 2023 (actual)
- 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 observational study includes patients at medium-to-high cardiovascular risks undergoing major noncardiac surgery, measures their baseline demographic and clinical characteristics, preoperative cardiac biomarkers and intraoperative surgery/anesthesia related data, and screens them for the occurrence of myocardial injury and major adverse cardiac events after surgery. The primary aim is to develop and validate a pre- and an immediate postoperative prediction model for occurrence of major adverse cardiac events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major noncardiac suregry with medium-to-high risks for postoperative cardiac complications.
Key inclusion criteria (3 listed)
- Age ≥ 45 years;
- Undergoing major noncardiac surgery (expected procedure duration ≥2 h, expected length of postoperative stay ≥2 d);
- History of at least one cardiovascular disease (i.e., coronary artery disease, stroke, congestive heart failure, or peripheral arterial disease) or with at least two cardiovascular risk factors (i.e., hypertension, diabetes, chronic kidney disease, smoking in the past ≥2 years, ≥65 years of age, hypercholesterolemia, history of TIA, high-risk surgery (intrathoracic, intraperitoneal, or major vascular)).
Key exclusion criteria (4 listed)
- History of acute cardiovascular events within 30 days prior to surgery;
- American Society of Anesthesiologists (ASA) physical status of 5 or greater;
- Previously enrolled in this study;
- Unable to understand or to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative cardiac biomarker measurementHigh-sensitivity cardiac troponin T is measured within 7 days prior to surgery and at day 1 and day 2 after surgery. N-terminal pro-B-type natriuretic peptide is measured within 7 days before surgery. | Diagnostic test | – |
Primary outcome
Number of patients with major adverse cardiac event
Time frame: Within 30 days after the index surgery
A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.
1 secondary outcome
Number of patients with myocardial injury after noncardiac suregry (MINS)
Time frame: Within 30 days after the index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
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 Noncardiac Surgery, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingcheng Zhao, MD (86-13763313653, zhaobch@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with major adverse cardiac event (time frame: Within 30 days after the index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.