Cardiac Complication After Vascular Surgery

Peripheral Arterial Disease Clinical Trial

— CCVS  

Official title:

The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188341
• Other study ID #: PomeranianMU
• Status: Completed
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 13, 2017
• Start date: December 2010
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiac Complication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Ventricular Arrythmia

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac complications	cardiac complications according to European Society of Cardiology	up to 30 days after vascular procedure
Secondary	cardiac complications	cardiac complications according to European Society of Cardiology	during surgical procedure
Secondary	cardiac complications	cardiac complications according to European Society of Cardiology	one year