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NCT05208957 Clinical Trial

Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

Perioperative Complication Clinical Trial

Official title:
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients. A Registry-based Study of in Hospital Mortality and Postoperative Complications in Elective Vascular Surgery at Groote Schuur Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05208957
Other study ID # HREC760/2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2022
Est. completion date December 2023

Study information
Verified date May 2022
Source University of Cape Town
Contact Christella Alphonsus, MBChB
Phone 021404
Email csalphonsus@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing vascular surgery: 1. 18 years and older 2. Elective procedures 3. Moderate- to high-risk surgical interventions Exclusion Criteria: 1. Emergency vascular procedures 2. Low risk vascular surgery, i.e. venous stripping 3. All non-vascular surgical interventions

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Cape Town

Outcome
Type Measure Description Time frame Safety issue
Primary Determine in-hospital mortality in elective vascular surgical patients 12 months
Secondary Determine incidence of MACE in elective vascular surgical patients. 12 months
Secondary Describe the risk factors associated with MACE in elective vascular surgical patients 12 months
Secondary Determine incidence of post-operative complications in elective vascular surgical patients 12 months
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