Lung CancerNCT05094843
The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery
An observational study of Lung Cancer and Surgery, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery, Arrhythmia
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2022to 31 Dec 2028
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective, curatively aimed, primary lung cancer surgery using mini-invasive surgical techniques.
Who may be able to join
- Adult patients scheduled for elective lung cancer surgery
- Willing to participate in the study
- Curatively aimed surgery
- Preoperative decision for mini-invasive surgery
Who cannot join
- Participation in any other clinical trial
- Previous chronic or paroxysmal atrial fibrillation or atrial flutter
- Cardiac pacemaker
- History of cardiac conduction disturbances including bundle branch blocks
- History of cardiac ablation procedures
- History of previous surgery in the thoracic area including open heart surgery
- Preoperatively anticipated need for concomitant thoracic wall resection
- Preoperatively anticipated need for open surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Heart Hospita, Tampere University Hospital
Tampere, Pirkanmaa, 33580
Jahangir Khan, MD, PhD
About this study
Official title: The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.
Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.
Read the detailed description
Lung cancer surgery causes significant acute changes in the small circulation as well as both transient and permanent changes in the intrathoracic anatomy. The electrocardiographic changes as well as their associations with postoperative recovery associated with modern mini-invasive lung cancer surgery have not been extensively studied.
The aims of the study are:
- To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
- To assess, whether perioperative electrocardiographic changes are associated with the postoperative recovery of these patients.
Altogether 100 patients with planned mini-invasive lung cancer surgery in the Tays Heart Hospital, Tampere, Finland, will be prospectively recruited for the study between the years 2021 and 2028.
The 12-lead rest electrocardiogram will be recorded from each patient preoperatively as well daily postoperatively and during follow-up out-patient clinic visit two weeks postoperatively. The perioperative continuous multi-lead electrocardiogram will be recorded. Laboratory examinations (cardiac troponins and natriuretic peptides) indicating cardiac stress will be obtained from the patients preoperatively and repeatedly postoperatively. The variables included in the electrocardiography analysis include cardiac rhythm, heart rate variability, PQ-time, QRS duration, P-, QRS, and T-wave amplitudes and axles, as well as ST-level variations.
Postoperative complications, including cardiac arrhythmias and myocardial ischemia and the duration of postoperative air leak and postoperative chest tube drainage, will be recorded. The associations between lung cancer surgery and electrocardiographic changes, their duration, as well as their associations with postoperative recovery will be analyzed using statistical methods.
A local study registry will be established for the study adhering to the legislature and protocols for clinical studies, including data security. Institutional ethics board committee approval has been obtained. The study will be registered in ClinicalTrials.gov prior to patient enrollment. The study does not include any interventions beside the normal treatment of these patients. Written informed consent will be obtained from each patient. The results of the study will be published in international medical journals.
- Conditions
- Lung Cancer, Surgery, Arrhythmia, Myocardial Ischemia
- Keywords
- Lung cancer, Electrocardiogram, Arrhythmia
- Medical subject headings
- Lung Neoplasms, Arrhythmias, Cardiac, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative electrocardiographic p-, R-, and T-wave amplitude changes
Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.
Measured: 2 weeks
Postoperative QRS-duration
The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.
Measured: 2 weeks
Postoperative PQ-delay
Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
Measured: 2 weeks
Postoperative QT-interval
The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
Measured: 2 weeks
The postoperative incidence of new bundle branch blocks
New complete or partial bundle branch blocks, such as RBBB, in the 12-lead rest electrocardiogram.
Measured: 2 weeks
Postoperative ST-level changes
ST-level changes in millimeters in the 12-lead rest electrocardiogram
Measured: 3 days
Postoperative P-wave, QRS-complex, and T-wave axle changes
The occurrence and type of P-wave, QRS-complex, and T-wave axle changes in the postoperative 12-lead rest electrocardiogram
Measured: 2 weeks
Postoperative heart rate
Postoperative heart rate variability in continuous electrocardiographic monitoring
Measured: 1 week
Postoperative arrhythmias
Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring
Measured: 1 week
Perioperative ST-level changes
The occurrence, duration (in minutes) as well as the magnitude (in millimeters) of perioperative ST-elevation or depression in the continuous perioperative electrocardiographic monitoring.
Measured: 1 day
Perioperative heart rate variability
Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.
Measured: 1 day
Perioperative arrhythmias
The occurrence and type of perioperative arrhythmias, such as atrial fibrillation or flutter, or ventricular tachycardia in the perioperative electrocardiographic monitoring.
Measured: 1 day
Perioperative R- and T-wave amplitude changes
The amplitude (in millimeters) of possible R- and T-wave amplitude changes in the perioperative electrocardiographic monitoring.
Measured: 1 day
Secondary outcomes (2)
Postoperative air leak
The presence and duration of (in days) postoperative air leak
Measured: 1 week
Need for reoperation
Need for reoperation due to for example bleeding.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- 100 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jahangir Khan, Principal investigator, MD, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094843
- Sponsor's protocol ID
- R21087
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2021
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.
- ClinicalTrials.gov ID
- NCT05094843
- Acronym / sponsor ID
- R21087
- Conditions
- Lung Cancer, Surgery, Arrhythmia, Myocardial Ischemia
- Keywords
- Lung cancer, Electrocardiogram, Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Oct 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.
Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.
Detailed description
Lung cancer surgery causes significant acute changes in the small circulation as well as both transient and permanent changes in the intrathoracic anatomy. The electrocardiographic changes as well as their associations with postoperative recovery associated with modern mini-invasive lung cancer surgery have not been extensively studied.
The aims of the study are:
- To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
- To assess, whether perioperative electrocardiographic changes are associated with the postoperative recovery of these patients.
Altogether 100 patients with planned mini-invasive lung cancer surgery in the Tays Heart Hospital, Tampere, Finland, will be prospectively recruited for the study between the years 2021 and 2028.
The 12-lead rest electrocardiogram will be recorded from each patient preoperatively as well daily postoperatively and during follow-up out-patient clinic visit two weeks postoperatively. The perioperative continuous multi-lead electrocardiogram will be recorded. Laboratory examinations (cardiac troponins and natriuretic peptides) indicating cardiac stress will be obtained from the patients preoperatively and repeatedly postoperatively. The variables included in the electrocardiography analysis include cardiac rhythm, heart rate variability, PQ-time, QRS duration, P-, QRS, and T-wave amplitudes and axles, as well as ST-level variations.
Postoperative complications, including cardiac arrhythmias and myocardial ischemia and the duration of postoperative air leak and postoperative chest tube drainage, will be recorded. The associations between lung cancer surgery and electrocardiographic changes, their duration, as well as their associations with postoperative recovery will be analyzed using statistical methods.
A local study registry will be established for the study adhering to the legislature and protocols for clinical studies, including data security. Institutional ethics board committee approval has been obtained. The study will be registered in ClinicalTrials.gov prior to patient enrollment. The study does not include any interventions beside the normal treatment of these patients. Written informed consent will be obtained from each patient. The results of the study will be published in international medical journals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective, curatively aimed, primary lung cancer surgery using mini-invasive surgical techniques.
Key inclusion criteria (4 listed)
- Adult patients scheduled for elective lung cancer surgery
- Willing to participate in the study
- Curatively aimed surgery
- Preoperative decision for mini-invasive surgery
Key exclusion criteria (8 listed)
- Participation in any other clinical trial
- Previous chronic or paroxysmal atrial fibrillation or atrial flutter
- Cardiac pacemaker
- History of cardiac conduction disturbances including bundle branch blocks
- History of cardiac ablation procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative electrocardiographic p-, R-, and T-wave amplitude changes
Time frame: 2 weeks
Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.
Postoperative QRS-duration
Time frame: 2 weeks
The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.
Postoperative PQ-delay
Time frame: 2 weeks
Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
Postoperative QT-interval
Time frame: 2 weeks
The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
The postoperative incidence of new bundle branch blocks
Time frame: 2 weeks
New complete or partial bundle branch blocks, such as RBBB, in the 12-lead rest electrocardiogram.
Postoperative ST-level changes
Time frame: 3 days
ST-level changes in millimeters in the 12-lead rest electrocardiogram
Postoperative P-wave, QRS-complex, and T-wave axle changes
Time frame: 2 weeks
The occurrence and type of P-wave, QRS-complex, and T-wave axle changes in the postoperative 12-lead rest electrocardiogram
Postoperative heart rate
Time frame: 1 week
Postoperative heart rate variability in continuous electrocardiographic monitoring
Postoperative arrhythmias
Time frame: 1 week
Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring
Perioperative ST-level changes
Time frame: 1 day
The occurrence, duration (in minutes) as well as the magnitude (in millimeters) of perioperative ST-elevation or depression in the continuous perioperative electrocardiographic monitoring.
Perioperative heart rate variability
Time frame: 1 day
Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.
Perioperative arrhythmias
Time frame: 1 day
The occurrence and type of perioperative arrhythmias, such as atrial fibrillation or flutter, or ventricular tachycardia in the perioperative electrocardiographic monitoring.
Perioperative R- and T-wave amplitude changes
Time frame: 1 day
The amplitude (in millimeters) of possible R- and T-wave amplitude changes in the perioperative electrocardiographic monitoring.
2 secondary outcomes
Postoperative air leak
Time frame: 1 week
Need for reoperation
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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.
Jahangir Khan principal investigator
MD, PhD
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 Lung Cancer and Surgery, run by Tampere University Hospital at 1 site in Finland.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Sep 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jahangir A Khan, MD, PhD (+3583311611, jahangir.khan@sydansairaala.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative electrocardiographic p-, R-, and T-wave amplitude changes (time frame: 2 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.