- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208957
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients
May 17, 2022 updated by: Christella Alphonsus, University of Cape Town
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
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christella Alphonsus, MBChB
- Phone Number: 5001 021404
- Email: csalphonsus@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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:
- 18 years and older
- Elective procedures
- Moderate- to high-risk surgical interventions
Exclusion Criteria:
- Emergency vascular procedures
- Low risk vascular surgery, i.e. venous stripping
- All non-vascular surgical interventions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine in-hospital mortality in elective vascular surgical patients
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine incidence of MACE in elective vascular surgical patients.
Time Frame: 12 months
|
12 months
|
Describe the risk factors associated with MACE in elective vascular surgical patients
Time Frame: 12 months
|
12 months
|
Determine incidence of post-operative complications in elective vascular surgical patients
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
December 1, 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)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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