COVID-19 VaccineNCT05348629
Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients
An observational study of COVID-19 Vaccine, run by Mina sobhi said fam at 2 sites in Egypt.
Trial summary
Efficacy and safety of covid-19 vaccine in Cardiac patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Vaccine
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Ages Eligible for Study : 18 Years to 80 Years Genders Eligible for Study : Male or female
Who may be able to join
- 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 .
Who cannot join
- 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 .
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Assiut University
Asyut, 71515
- Recruiting
Assiut university
Asyut, 71515
Mina Fam, Resident, +201122035368, minassfam@yahoo.com
About this study
Efficacy and safety of covid-19 vaccine in Cardiac patients
Read the detailed description
investigate the efficacy and safety of covid-19 vaccine in cardiac patients and its possible assocciated morbidity
- Conditions
- COVID-19 Vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
all cause mortality
Measured: one year
Myocardial infarction
Myocardial infarction
Measured: one year
stent thrombosis
stent thrombosis
Measured: one year
Secondary outcomes (4)
Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death
Cardiovascular death.
Measured: one year
heart failure hospitalization
heart failure hospitalization
Measured: one year
infection by covid-19
infection by covid-19
Measured: one year
anaphylaxis required hospitalization
anaphylaxis required hospitalization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mina sobhi said fam
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Mina sobhi said fam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348629
- Sponsor's protocol ID
- covid-19 vaccine
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients
- ClinicalTrials.gov ID
- NCT05348629
- Acronym / sponsor ID
- covid-19 vaccine
- Conditions
- COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mina sobhi said famUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ages Eligible for Study : 18 Years to 80 Years Genders Eligible for Study : Male or female
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: one year
all cause mortality
Myocardial infarction
Time frame: one year
Myocardial infarction
stent thrombosis
Time frame: one year
stent thrombosis
4 secondary outcomes
Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death
Time frame: one year
heart failure hospitalization
Time frame: one year
infection by covid-19
Time frame: one year
anaphylaxis required hospitalization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccine, run by Mina sobhi said fam at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Fam, Residuant (+201122035368, minassfam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.