Perioperative Troponin I and NT Pro-BNP in Lung Resection

NCT04749212 | Completed

• 1 other identifier: 621/2020
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Ischemia; Thoracic Cancer; Complication,Postoperative

Outcome Measures

Primary Outcomes (3)

• NT-proBNP perioperative changes

  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

  Change from baseline NT-proBNP at two-days after surgery

• TnI perioperative changes

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

  Change from baseline TnI at two-days after surgery

• Major cardiovascular complications

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

  30-days after surgery

Interventions

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adulty patients undergoing elective thoracic and lung resection surgery: neumonectomy, lobectomy, bilobectomy or segmentectomy

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Related Publications (1)

• Alonso M, Popova E, Martin-Grande A, Perez-Velez J, Trujillo JC, Gajate L, de Miguel M, Gonzalez-Tallada A, Martinez-Tellez E, Cladellas-Gutierrez E, Planas G, de Pablo A, Parise D, Candela-Toha A, de Nadal M. Study protocol for an observational cohort evaluating incidence and clinical relevance of perioperative elevation of high-sensitivity troponin I and N-terminal pro-brain natriuretic peptide in patients undergoing lung resection. BMJ Open. 2022 Dec 8;12(12):e063778. doi: 10.1136/bmjopen-2022-063778.

  PMID: 36600389 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 11, 2021
• Study Start: May 19, 2021
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)