Gender DiscriminationNCT05710796
AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS
An observational study of Gender Discrimination and Cardiac Event, run by Kakatiya University at 1 site in India.
Trial summary
Aim of the study is to evaluate the prevalence and bring awareness ofcardiovascular complications in COVID-19 recovered patients. Study is conducted at single site, which is Srinivasa Heart Centre, Warangal, Telangana state in India for the duration of 4 months. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gender Discrimination, Cardiac Event, Complication
- What is being tested?
- Difference in gender, response to disease, diagnostic test values
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2021to 29 Apr 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient reporting to the cardiology department during study period
Who may be able to join
- Patients who are willing to participate
- Patients having previous COVID-19 treatment record
- Prescriptions reported during the study period
- The prescription which is legible and complete
Who cannot join
- Patients who are not willing to participate
- The patient having no history of COVID-19 and available data
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to evaluate the prevalence and bring awareness ofcardiovascular complications in COVID-19 recovered patients. Study is conducted at single site, which is Srinivasa Heart Centre, Warangal, Telangana state in India for the duration of 4 months. The sample size is calculated 500 patients and the study is cohort, observational study. Patient consent has been taken before enrolment.
Read the detailed description
The aim of the study is to evaluate the prevalence and bring awareness of cardiovascular complications in COVID-19 recovered patients.
Objectives of the study:
- To study causes and risk factors of cardiac disorders associated with COVID-19
- To identify different types of cardiac symptoms patients, present with
- To study the impact of co-morbidities on COVID-19 recovered patients
- To study treatment patterns and duration of therapy
Plan to study:
- To select the patient based on inclusion and exclusion criteria
- To collect the patient information from case sheets and by patient interaction
- To identify different types of cardiac disorders related to COVID-19 or its treatment regimen
- To study the management of COVID-19 complication and related cardiovascular disorders
Study Sites: Srinivasa Heart Centre, Warangal (T.S) Study Design: Observational cohort study Study Duration: 4 months
Subject Eligibility:
- Inclusion Criteria
- Patients who are willing to participate
- Patients having previous COVID-19 treatment record
- Prescriptions reported during the study period
- The prescription which is legible and complete
- Exclusion Criteria
- Patients who are not willing to participate
- The patient having no history of COVID-19 and available data
Source of the data:
- Review of patient case sheet, prescription and lab reports
- Personal interaction with patients and caregivers
Sample size: 500 Patients
- Conditions
- Gender Discrimination, Cardiac Event, Complication
- Being tested
- Difference in gender, response to disease, diagnostic test values
- Keywords
- Cardiovascular involvement, COVID 19 disease, Gender difference
- Medical subject headings
- Sexism, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difference in gender, response to disease, diagnostic test valuesBehavioural
Gender difference: Prevalence of disease in male vs female Response to disease: Which group is more prone to cardiac involvement Diagnostic tests: Diagnostic confirmation of disease
| Study group | Role | What they receive |
|---|---|---|
| All population | The total population reported to Cardiology department during enrollment period Receives: Behavioral: Difference in gender, response to disease, diagnostic test values | |
| COVID recovered | Patient having history of COVID 19 disease Receives: Behavioral: Difference in gender, response to disease, diagnostic test values | |
| No history of COVID | Population those who never exposed to COVID 19 disease and never suffers Receives: Behavioral: Difference in gender, response to disease, diagnostic test values |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG, Lipid profile, TMT, and 2D Echo
The following tests are performed to every individuals and relevant report are considered
Measured: September 2021 to February 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DiscriminationStudies 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kakatiya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satyam Suman, Kakatiya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710796
- Sponsor's protocol ID
- IECHS/CCP/DOPP/09/04
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be in future it will be needed
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS
- ClinicalTrials.gov ID
- NCT05710796
- Acronym / sponsor ID
- IECHS/CCP/DOPP/09/04
- Conditions
- Gender Discrimination, Cardiac Event, Complication
- Keywords
- Cardiovascular involvement, COVID 19 disease, Gender difference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kakatiya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 2 Feb 2023 (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.
Aim of the study is to evaluate the prevalence and bring awareness ofcardiovascular complications in COVID-19 recovered patients. Study is conducted at single site, which is Srinivasa Heart Centre, Warangal, Telangana state in India for the duration of 4 months. The sample size is calculated 500 patients and the study is cohort, observational study. Patient consent has been taken before enrolment.
Detailed description
The aim of the study is to evaluate the prevalence and bring awareness of cardiovascular complications in COVID-19 recovered patients.
Objectives of the study:
- To study causes and risk factors of cardiac disorders associated with COVID-19
- To identify different types of cardiac symptoms patients, present with
- To study the impact of co-morbidities on COVID-19 recovered patients
- To study treatment patterns and duration of therapy
Plan to study:
- To select the patient based on inclusion and exclusion criteria
- To collect the patient information from case sheets and by patient interaction
- To identify different types of cardiac disorders related to COVID-19 or its treatment regimen
- To study the management of COVID-19 complication and related cardiovascular disorders
Study Sites: Srinivasa Heart Centre, Warangal (T.S) Study Design: Observational cohort study Study Duration: 4 months
Subject Eligibility:
- Inclusion Criteria
- Patients who are willing to participate
- Patients having previous COVID-19 treatment record
- Prescriptions reported during the study period
- The prescription which is legible and complete
- Exclusion Criteria
- Patients who are not willing to participate
- The patient having no history of COVID-19 and available data
Source of the data:
- Review of patient case sheet, prescription and lab reports
- Personal interaction with patients and caregivers
Sample size: 500 Patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All population | – | Behavioral: Difference in gender, response to disease, diagnostic test valuesThe total population reported to Cardiology department during enrollment period |
| COVID recovered | – | Behavioral: Difference in gender, response to disease, diagnostic test valuesPatient having history of COVID 19 disease |
| No history of COVID | – | Behavioral: Difference in gender, response to disease, diagnostic test valuesPopulation those who never exposed to COVID 19 disease and never suffers |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient reporting to the cardiology department during study period
Key inclusion criteria (4 listed)
- Patients who are willing to participate
- Patients having previous COVID-19 treatment record
- Prescriptions reported during the study period
- The prescription which is legible and complete
Key exclusion criteria (2 listed)
- Patients who are not willing to participate
- The patient having no history of COVID-19 and available data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difference in gender, response to disease, diagnostic test valuesGender difference: Prevalence of disease in male vs female Response to disease: Which group is more prone to cardiac involvement Diagnostic tests: Diagnostic confirmation of disease | Behavioural | All population, COVID recovered, No history of COVID |
Primary outcome
ECG, Lipid profile, TMT, and 2D Echo
Time frame: September 2021 to February 2022
The following tests are performed to every individuals and relevant report are considered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Undecided. May be in future it will be needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Discrimination and Cardiac Event, run by Kakatiya University at 1 site in India.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG, Lipid profile, TMT, and 2D Echo (time frame: September 2021 to February 2022). 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 3 Feb 2023.