AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS

Complication Clinical Trial

Official title:

AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710796
• Other study ID #: IECHS/CCP/DOPP/09/04
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: February 2023
• Source: Kakatiya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 29, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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

Related Conditions & MeSH terms

• Cardiac Event
• Complication

Intervention

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

Locations

Country	Name	City	State
India	Srinivasa Heart Centre	Warangal	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Kakatiya University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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