Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

COVID-19 Vaccine Clinical Trial

Official title:

Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348629
• Other study ID #: covid-19 vaccine
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Mina Fam, Residuant
• Phone: +201122035368
• Email: minassfam[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Efficacy and safety of covid-19 vaccine in Cardiac patients

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccine

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut
Egypt	Assiut university	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Mina sobhi said fam	Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality	all cause mortality	one year
Primary	Myocardial infarction	Myocardial infarction	one year
Primary	stent thrombosis	stent thrombosis	one year
Secondary	Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death	Cardiovascular death.	one year
Secondary	heart failure hospitalization	heart failure hospitalization	one year
Secondary	infection by covid-19	infection by covid-19	one year
Secondary	anaphylaxis required hospitalization	anaphylaxis required hospitalization	one year