Cardiac IschemiaNCT04749212
Perioperative Troponin I and NT Pro-BNP in Lung Resection
An observational study of Cardiac Ischemia and Thoracic Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiac Ischemia, Thoracic Cancer, Complication,Postoperative
- What is being tested?
- serum high-sensitivity Troponin I (TnI) and NT-Pro-Brain Natriuretic Peptide (NT-proBNP)
- How many people
- 475 participants
- Where
- 1 siteSpain
- Study dates
- 19 May 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adulty patients undergoing elective thoracic and lung resection surgery: neumonectomy, lobectomy, bilobectomy or segmentectomy
Who may be able to join
- Age ≥45 years old
- Patients undergoing elective surgery for lung resection
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- serum high-sensitivity Troponin I (TnI) and NT-Pro-Brain Natriuretic Peptide (NT-proBNP)
- Medical subject headings
- Coronary Artery Disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30-days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start19 May 2021
- Primary completion30 Nov 2023
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749212
- Sponsor's protocol ID
- 621/2020
- Status last verified
- Mar 2025
- First submitted
- 18 Jan 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alonso M, Popova E, De Miguel M, Garcia-Osuna A, Gonzalez-Tallada A, Ordonez-Llanos J, Jauregui A, Trujillo JC, Martin Grande A, Martinez-Tellez E, Parera A, Planas G, Trujillo L, Butron D, Sola-Roca J, De Nadal M. N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study. BMJ Open. 2026 Apr 17;16(4):e108073. doi: 10.1136/bmjopen-2025-108073.
PubMed 41997702Alonso 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.
PubMed 36600389
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Relevance of Perioperative Elevation of Troponin I and N- Terminal Pro-Brain Natriuretic Peptide in Patients Undergoing Lung Resection
- ClinicalTrials.gov ID
- NCT04749212
- Acronym / sponsor ID
- 621/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adulty patients undergoing elective thoracic and lung resection surgery: neumonectomy, lobectomy, bilobectomy or segmentectomy
Key inclusion criteria (2 listed)
- Age ≥45 years old
- Patients undergoing elective surgery for lung resection
Key exclusion criteria (4 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 41997702Alonso M, Popova E, De Miguel M, Garcia-Osuna A, Gonzalez-Tallada A, Ordonez-Llanos J, Jauregui A, Trujillo JC, Martin Grande A, Martinez-Tellez E, Parera A, Planas G, Trujillo L, Butron D, Sola-Roca J, De Nadal M. N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study. BMJ Open. 2026 Apr 17;16(4):e108073. doi: 10.1136/bmjopen-2025-108073.
- Derived from this study: PubMed 36600389Alonso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Ischemia and Thoracic Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP perioperative changes (time frame: Change from baseline NT-proBNP at two-days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749212, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.