Perioperative Troponin I and NT Pro-BNP in Lung Resection

NCT ID: NCT04749212

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-19

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Ischemia Thoracic Cancer Complication,Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 36600389 (View on PubMed)

Other Identifiers

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621/2020

Identifier Type: -

Identifier Source: org_study_id

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