Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

April 25, 2022 updated by: Mina sobhi said fam
Efficacy and safety of covid-19 vaccine in Cardiac patients

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

50

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

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 .

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death
Time Frame: one year
Cardiovascular death.
one year
heart failure hospitalization
Time Frame: one year
heart failure hospitalization
one year
infection by covid-19
Time Frame: one year
infection by covid-19
one year
anaphylaxis required hospitalization
Time Frame: one year
anaphylaxis required hospitalization
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mina sobhi said fam

Collaborators

Assiut University

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, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • covid-19 vaccine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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