Emergency Coronary Artery Bypass Graft in Acute Myocardia... | NCT04572061

Studies
Emergency Coronary Artery Bypass Graft in Acute Myocardial Infarction

NCT04572061

Sponsor

Saud Al Babtain Cardiac Center

Status

Completed

Last Update Posted

Oct 1, 2020Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

Saudi Arabia

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

Sep 2020

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

Feb 7, 2017Actual

Primary Completion Date

Oct 31, 2017Actual

Completion Date

Jul 31, 2018Actual

First Submitted Date

Jun 14, 2020

First Submission Date that Met QC Criteria

Sep 27, 2020

First Posted Date

Oct 1, 2020Actual

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

Sep 27, 2020

Last Update Posted Date

Oct 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A retrospective study investigating the early outcome of emergency CABG post MI in patients who were operated at Saud Al Babtain Cardiac Center.

Detailed Description

A retrospective study of surgical patients who underwent Coronary Artery Bypass Graft for Acute Myocardial Infarction between December 2013 and February 2018 determining outcomes on morbidity and mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STEMI and Emergency CABG	Evaluate patients the early outcome of emergency CABG post MI.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with post cardiogenic shock who underwent CABG
=/> 17 years old

Exclusion Criteria:

Patients other than post cardiogenic shock who underwent CABG or any cardiac surgeries
<17 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All adult patients admitted at Saud Al Babtain Cardiac Center with post cardiogenic shock who underwent CABG.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Attiea, MD	Saud Al Babtain Cardiac Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saud Al Babtain Cardiac Center		Dammam		31463	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided