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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03188341
Other study ID # PomeranianMU
Secondary ID
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
Health authority
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

Study Design


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
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