NCT04819698

Brief Summary

This observational study will describe the incidence and risk factors of perioperative cardiac complications (PCCs) in patients undergoing non-cardiac surgery in Tibet Autonomous Region. And perioperative troponin monitoring will be implemented in these population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

March 24, 2021

Last Update Submit

March 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative cardiac complications

    Perioperative cardiac complications are defined as acute coronary syndrome (ACS), heart failure, new-onset severe arrhythmia, nonfatal cardiac arrest, and cardiac death. ACS included ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS). NSTE-ACS could be further subdivided into non-ST-elevation myocardial infarction and unstable angina according to the cardiac biomarkers.

    Participants will be followed for 30 days after surgery

Interventions

cTnI will be measured at baseline prior to surgery, as well as on 1h,12h, 24h and 72h after surgery for each patient in study B.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 50 years or older undergoing intermediate to high-risk elective noncardiac surgery.

You may qualify if:

  • Patients aged 50 years or older;
  • Undergoing intermediate to high-risk elective noncardiac surgery .

You may not qualify if:

  • Emergency surgery;
  • Local anesthesia;
  • Low-risk surgery;
  • ASA classification V or VI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

  • Zhu Q, Duan H, Liu Z, Li Y, Zhang Y, Labaciren, Shen L, Huang Y. The incidence and risk factors of perioperative cardiac complications in noncardiac major surgery in high-altitude areas: A prospective trial in Tibet autonomous region, China. Front Cardiovasc Med. 2023 Apr 3;10:1158711. doi: 10.3389/fcvm.2023.1158711. eCollection 2023.

MeSH Terms

Interventions

Troponin I

Intervention Hierarchy (Ancestors)

TroponinMultiprotein ComplexesMacromolecular SubstancesMicrofilament ProteinsBiopolymersPolymersMuscle ProteinsContractile ProteinsProteinsAmino Acids, Peptides, and ProteinsCytoskeletal Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations