Perioperative Troponin I and NT Pro-BNP in Lung Resection

August 31, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline NT-proBNP at two-days after surgery
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
Change from baseline TnI at two-days after surgery
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
30-days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 621/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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