The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094843
• Other study ID #: R21087
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2022
• Source: Tampere University Hospital
• Contact: Jahangir A Khan, MD, PhD
• Phone: +3583311611
• Email: jahangir.khan[@]sydansairaala.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Ischemia
• Lung Cancer
• Lung Neoplasms
• Myocardial Ischemia
• Surgery

Locations

Country	Name	City	State
Finland	Heart Hospita, Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative electrocardiographic p-, R-, and T-wave amplitude changes	Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.	2 weeks
Primary	Postoperative QRS-duration	The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.	2 weeks
Primary	Postoperative PQ-delay	Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.	2 weeks
Primary	Postoperative QT-interval	The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.	2 weeks
Primary	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
Primary	Postoperative ST-level changes	ST-level changes in millimeters in the 12-lead rest electrocardiogram	3 days
Primary	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
Primary	Postoperative heart rate	Postoperative heart rate variability in continuous electrocardiographic monitoring	1 week
Primary	Postoperative arrhythmias	Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring	1 week
Primary	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
Primary	Perioperative heart rate variability	Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.	1 day
Primary	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
Primary	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	Postoperative air leak	The presence and duration of (in days) postoperative air leak	1 week
Secondary	Need for reoperation	Need for reoperation due to for example bleeding.	1 week