Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients | NCT05348629

Studies
Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

NCT05348629

Sponsor

Mina sobhi said fam

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

COVID-19 Vaccine

Interventions

Not provided

Countries

Egypt

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Sep 1, 2023Estimated

First Submitted Date

Mar 31, 2022

First Submission Date that Met QC Criteria

Apr 25, 2022

First Posted Date

Apr 27, 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

Apr 25, 2022

Last Update Posted Date

Apr 27, 2022Actual

Name	Class
Assiut University	OTHER

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

Efficacy and safety of covid-19 vaccine in Cardiac patients

Detailed Description

investigate the efficacy and safety of covid-19 vaccine in cardiac patients and its possible assocciated morbidity

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality	all cause mortality	one year
Myocardial infarction	Myocardial infarction	one year
stent thrombosis	stent thrombosis	one year

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death	Cardiovascular death.	one year
heart failure hospitalization	heart failure hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed as STEMI undergo PPCI as (Fourth universal definition of myocardial infarction (2018) Kristian Thygesen) 10
with age range from 18 to 80 years after 1 month of STEMI .

Exclusion Criteria:

Patients with previous covid infection confirmed by swap or CT chest or ICU addmision.
Patients with previous covid infection confirmed by qualitative antibdy test .
Patients with history of anaphylaxis to any component of the vaccine should not take it .
patients with febrile illness or acute , ongoing infection .
immunosuppressive diseases .

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Ages Eligible for Study : 18 Years to 80 Years Genders Eligible for Study : Male or female

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mina Fam, Residuant	Contact	+201122035368		minassfam@yahoo.com
Aly Tohamy, Lecturer	Contact	+201006258877		Ali.tohamy@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut		71515	Egypt
Assiut university

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided