Clinical Trials Directory

Trials / Completed

CompletedNCT03188341

Cardiac Complication After Vascular Surgery

The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Pomeranian Medical University Szczecin · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERvascular 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)

Timeline

Start date
2010-12-01
Primary completion
2016-12-01
Completion
2017-06-01
First posted
2017-06-15
Last updated
2017-06-15

Source: ClinicalTrials.gov record NCT03188341. Inclusion in this directory is not an endorsement.