AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS

Completed

• Conditions: Complication; Gender Discrimination; Cardiac Event
• Interventions: Behavioral: Difference in gender, response to disease, diagnostic test values

• Registration Number: NCT05710796
• Lead Sponsor: Kakatiya University

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.

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:

1. To study causes and risk factors of cardiac disorders associated with COVID-19

2. To identify different types of cardiac symptoms patients, present with

3. To study the impact of co-morbidities on COVID-19 recovered patients

4. 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:

1. 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

2. Exclusion Criteria

* Patients who are not willing to participate

* The patient having no history of COVID-19 and available data

Source of the data:

1. Review of patient case sheet, prescription and lab reports

2. Personal interaction with patients and caregivers

Sample size: 500 Patients

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-04-29
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No history of COVID	Difference in gender, response to disease, diagnostic test values	Population those who never exposed to COVID 19 disease and never suffers
All population	Difference in gender, response to disease, diagnostic test values	The total population reported to Cardiology department during enrollment period
COVID recovered	Difference in gender, response to disease, diagnostic test values	Patient having history of COVID 19 disease

Primary Outcome Measures

Name	Time	Method
ECG, Lipid profile, TMT, and 2D Echo	September 2021 to February 2022	The following tests are performed to every individuals and relevant report are considered

Trial Locations

Locations (1)

Srinivasa Heart Centre; 🇮🇳 Warangal, Telangana, India