NCT05348629

Brief Summary

Efficacy and safety of covid-19 vaccine in Cardiac patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

March 31, 2022

Last Update Submit

April 25, 2022

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (3)

  • all cause mortality

    all cause mortality

    one year

  • Myocardial infarction

    Myocardial infarction

    one year

  • stent thrombosis

    stent thrombosis

    one year

Secondary Outcomes (4)

  • Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death

    one year

  • heart failure hospitalization

    one year

  • infection by covid-19

    one year

  • anaphylaxis required hospitalization

    one year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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 .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Assiut university

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

Mina Fam, Residuant

CONTACT

+201122035368minassfam@yahoo.com

Aly Tohamy, Lecturer

CONTACT

+201006258877Ali.tohamy@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 27, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2023

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

EG(2)