AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS

• Sponsor: Kakatiya University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05710796
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 63.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gender Discrimination; Cardiac Event; Complication	Behavioral: Difference in gender, response to disease, diagnostic test values

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

1. 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 Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: Apr 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
All population The total population reported to Cardiology department during enrollment period	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
COVID recovered Patient having history of COVID 19 disease	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
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; 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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Srinivasa Heart Centre	Warangal	Telangana	India	506001

Sponsors and Collaborators

• Kakatiya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Satyam Suman, Department of Pharmacy Practice, Kakatiya University
• ClinicalTrials.gov Identifier: NCT05710796
• Other Study ID Numbers: IECHS/CCP/DOPP/09/04
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 3, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Satyam Suman, Department of Pharmacy Practice, Kakatiya University: Cardiovascular involvement; COVID 19 disease; Gender difference

Study Results

No Results Posted as of Feb 3, 2023