Perioperative Troponin I and NT Pro-BNP in Lung Resection

Thoracic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749212
• Other study ID #: 621/2020
• Status: Recruiting
• Start date: May 19, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Miriam De Nadal Clanchet, MD, PhD
• Phone: 934 89 30 00
• Email: miriam.denadal[@]vallhebron.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Ischemia
• Complication,Postoperative
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Postoperative Complications
• Thoracic Cancer

Intervention

Diagnostic Test:
• serum high-sensitivity Troponin I (TnI) and NT-Pro-Brain Natriuretic Peptide (NT-proBNP)
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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