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NCT Number: NCT05812248

Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort 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.

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Key information

Conditions

Noncardiac Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Bingcheng Zhao, MD

CONTACT

[email protected]

86-13763313653

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)).

Exclusion criteria

  • 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.

Treatment and study plan

Perioperative cardiac biomarker measurement

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of patients with myocardial injury after noncardiac suregry (MINS)

    Time frame: Within 30 days after the index surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingcheng Zhao, MD

CONTACT

[email protected]

86-13763313653

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Acronym: PREVENGE-CB-2

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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