Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Complication; Cardiovascular Complication
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7708
      • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises all patients, 18 years and older, undergoing any elective moderate- to high-risk vascular surgical intervention at Groote Schuur Hospital. Surgical risk as defined by ESC/ESA 2014 guidelines.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine in-hospital mortality in elective vascular surgical patients	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine incidence of MACE in elective vascular surgical patients.	12 months
Describe the risk factors associated with MACE in elective vascular surgical patients	12 months
Determine incidence of post-operative complications in elective vascular surgical patients	12 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: Christella Alphonsus, MBChB, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HREC760/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared by PI
• IPD Sharing Time Frame: Not limited
• IPD Sharing Access Criteria: Contact PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No