NCT05710796

Brief 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. The sample size is calculated 500 patients and the study is cohort, observational study. Patient consent has been taken before enrolment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 30, 2023

Last Update Submit

February 1, 2023

Conditions

Keywords

Cardiovascular involvementCOVID 19 diseaseGender difference

Outcome Measures

Primary Outcomes (1)

  • ECG, Lipid profile, TMT, and 2D Echo

    The following tests are performed to every individuals and relevant report are considered

    September 2021 to February 2022

Study Arms (3)

All population

The total population reported to Cardiology department during enrollment period

Behavioral: Difference in gender, response to disease, diagnostic test values

COVID recovered

Patient having history of COVID 19 disease

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

Behavioral: Difference in gender, response to disease, diagnostic test values

Interventions

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

All populationCOVID recoveredNo history of COVID

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient reporting to the cardiology department during study period

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are not willing to participate
  • The patient having no history of COVID-19 and available data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinivasa Heart Centre

Warangal, Telangana, 506001, India

Location

MeSH Terms

Conditions

SexismCardiovascular Diseases

Interventions

Sex

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pharmacy Practice

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 2, 2023

Study Start

September 1, 2021

Primary Completion

February 1, 2022

Study Completion

April 29, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations