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NCT Number: NCT05094843

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Hospita, Tampere University Hospital

Tampere, Pirkanmaa, 33580, Finland

Location status: Recruiting

Location contact

Jahangir Khan, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients scheduled for elective lung cancer surgery
  • Willing to participate in the study
  • Curatively aimed surgery
  • Preoperative decision for mini-invasive surgery

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Postoperative PQ-delay

    Time frame: 2 weeks

    Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

  4. Postoperative QT-interval

    Time frame: 2 weeks

    The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

  5. 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.

  6. Postoperative ST-level changes

    Time frame: 3 days

    ST-level changes in millimeters in the 12-lead rest electrocardiogram

  7. 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

  8. Postoperative heart rate

    Time frame: 1 week

    Postoperative heart rate variability in continuous electrocardiographic monitoring

  9. Postoperative arrhythmias

    Time frame: 1 week

    Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring

  10. 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.

  11. Perioperative heart rate variability

    Time frame: 1 day

    Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.

  12. 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.

  13. 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.

Secondary outcomes

  1. Postoperative air leak

    Time frame: 1 week

    The presence and duration of (in days) postoperative air leak

  2. Need for reoperation

    Time frame: 1 week

    Need for reoperation due to for example bleeding.

Study contacts

Contact information is provided by the study sponsor or research team.

Jahangir A Khan, MD, PhD

CONTACT

[email protected]

+3583311611

Kati Helleharju, RC

CONTACT

[email protected]

+358504361303

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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