Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

• Sponsor: University of Cape Town (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05208957
• Collaborator: (none)
• Enrollment: 400
• Anticipated Duration (Months): 18

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Complication; Cardiovascular Complication	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Determine in-hospital mortality in elective vascular surgical patients [12 months]

Secondary Outcome Measures

1. Determine incidence of MACE in elective vascular surgical patients. [12 months]

2. Describe the risk factors associated with MACE in elective vascular surgical patients [12 months]

3. Determine incidence of post-operative complications in elective vascular surgical patients [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Cape Town

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christella Alphonsus, Study Principal investigator, University of Cape Town
• ClinicalTrials.gov Identifier: NCT05208957
• Other Study ID Numbers: HREC760/2021
• First Posted: Jan 26, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 18, 2022