Cardiovascular Outcomes and Mortality in Vascular Surgica... | NCT05208957

Studies
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

NCT05208957

Sponsor

University of Cape Town

Status

Completed

Last Update Posted

Jul 16, 2024Actual

Enrollment

175Actual

Phase

Not provided

Conditions

Perioperative Complication
Cardiovascular Complication

Interventions

No intervention

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2022Actual

Primary Completion Date

Nov 30, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Jan 25, 2022

First Posted Date

Jan 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2024

Last Update Posted Date

Jul 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christella Alphonsus, Study Principal investigator, University of Cape TownPrincipal Investigator

Lead Sponsor

University of Cape TownOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christella Alphonsus, MBChB	University of Cape Town	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groote Schuur Hospital		Cape Town	Western Cape	7708	South Africa

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared by PI

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not limited

Access Criteria

Contact PI

URL

Not provided