CCVS: Cardiac Complication After Vascular Surgery

Sponsor

Pomeranian Medical University Szczecin (Other)

Overall Status

Completed

CT.gov ID

NCT03188341

Collaborator

(none)

100

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.

Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.

Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Ventricular Arrythmia Peripheral Arterial Disease Cardiac Complication	Other: vascular surgery procedure

Detailed Description

Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery

Actual Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
vascular surgery patients clinically concealed repolarization disturbances during vascular surgery procedure clinically disclosed cardiac complications during and after vascular surgery procedure	Other: vascular surgery procedure an elective "open" vascular surgery procedure ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

Arm

Intervention/Treatment

vascular surgery patients

clinically concealed repolarization disturbances during vascular surgery procedure clinically disclosed cardiac complications during and after vascular surgery procedure

Other: vascular surgery procedure

an elective "open" vascular surgery procedure ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

Outcome Measures

Primary Outcome Measures

cardiac complications [up to 30 days after vascular procedure]
cardiac complications according to European Society of Cardiology

Secondary Outcome Measures

cardiac complications [during surgical procedure]
cardiac complications according to European Society of Cardiology
cardiac complications [one year]
cardiac complications according to European Society of Cardiology

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure

Exclusion Criteria:

heart stimulation,
atrioventricular and intraventricular conduction defects,
atrial fibrillation recorded before of the study,
antiarrhythmic drug treatment (except beta-blockers),
unoptimal patient general status (uncontrolled diabetes, active infection)
reoperation
emergency operations

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pomeranian Medical University Szczecin

Investigators

Principal Investigator: Jowita Biernawska, MD, PhD, Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.