The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Lung Cancer; Arrhythmia; Surgery

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:

1. To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
2. 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jahangir A Khan, MD, PhD; Phone Number: +3583311611; Email: jahangir.khan@sydansairaala.fi
• Study Contact Backup: Name: Kati Helleharju, RC; Phone Number: +358504361303; Email: kati.helleharju@sydansairaala.fi

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33580
      • Recruiting
      • Heart Hospita, Tampere University Hospital
      • Contact: Jahangir Khan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective, curatively aimed, primary lung cancer surgery using mini-invasive surgical techniques.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative electrocardiographic p-, R-, and T-wave amplitude changes	Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.	2 weeks
Postoperative QRS-duration	The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.	2 weeks
Postoperative PQ-delay	Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.	2 weeks
Postoperative QT-interval	The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.	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.	2 weeks
Postoperative ST-level changes	ST-level changes in millimeters in the 12-lead rest electrocardiogram	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	2 weeks
Postoperative heart rate	Postoperative heart rate variability in continuous electrocardiographic monitoring	1 week
Postoperative arrhythmias	Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring	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.	1 day
Perioperative heart rate variability	Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.	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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative air leak	The presence and duration of (in days) postoperative air leak	1 week
Need for reoperation	Need for reoperation due to for example bleeding.	1 week

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Jahangir Khan, MD, PhD

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2028
• Study Completion (ANTICIPATED): December 31, 2028

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (ACTUAL): October 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Arrhythmia; Lung cancer; Electrocardiogram
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Myocardial Ischemia; Lung Neoplasms; Ischemia; Arrhythmias, Cardiac
• Other Study ID Numbers: R21087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No