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Completed

NCT Number: NCT04749212

Perioperative Troponin I and NT Pro-BNP in Lung Resection

After lung resection, troponin elevation may be regulated by mechanisms other than myocardial ischemia. Perioperative natriuretic peptides measurement may help identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection.

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Key information

Conditions

Cardiac Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Complication,Postoperative Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Thoracic Cancer Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

About this study

Objectives: To evaluate the incidence and magnitude of perioperative N-terminal pro brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin I (Tn I) elevation in patients undergoing pulmonary resection and its predictive value for cardiovascular complications. Methodology: Prospective, multicenter, observational cohort study in patients >45 years undergoing elective thoracic surgery for lung resection. Cardiac biomarkers Tn I and NT-proBNP will be measured preoperatively and at postoperative days 1 and 2. Risk score for major cardiovascular postoperative complications will be calculated depending of both biomarkers perioperative changes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥45 years old
  • Patients undergoing elective surgery for lung resection

Exclusion criteria

  • Patients undergoing urgent, emergent, or nonthoracic surgery
  • Patients or family did not consent to participate
  • Presence of symptoms related with infection or sepsis
  • Patients with a documented history of severe heart failure and/or ejection fraction lower than 30%

Treatment and study plan

serum high-sensitivity Troponin I (TnI) and NT-Pro-Brain Natriuretic Peptide (NT-proBNP)

Diagnostic Test

Both biomarkers will be determined in each patient preoperatively and at postoperative day 1 and day 2.Measurements will not necessarily be taken independently of other measurements, meaning that the addition of the biomarker could be included in routine pre or postoperative day-1 and day 2 blood tests.

Primary outcomes

  1. NT-proBNP perioperative changes

    Time frame: Change from baseline NT-proBNP at two-days after surgery

    Perioperative change in NT-Pro-Brain Natriuretic Peptide (NT-proBNP) levels in patients undergoing pulmonary resection. Cutt-of values will be NT-proBNP ≥ 300 pg/ml pg/ml

  2. TnI perioperative changes

    Time frame: Change from baseline TnI at two-days after surgery

    Perioperative changes in high-sensitivity troponin I (TnI) levels in patients undergoing pulmonary resection. Cutt-of values will be TnI ≥45 ng/L

  3. Major cardiovascular complications

    Time frame: 30-days after surgery

    Postoperative non-fatal cardiac arrest, acute myocardial infarction, angina, congestive heart failure, new clinically relevant cardiac arrhythmia, cardiovascular death

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Incidence and Clinical Relevance of Perioperative Elevation of Troponin I and N- Terminal Pro-Brain Natriuretic Peptide in Patients Undergoing Lung Resection

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Feb 11, 2021
Registry last updated
Mar 13, 2025

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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