Cardiovascular Risk Factors , Complications and Threputic Management Strategies in Patients With Coronary Heart Disease and COVID 19

NCT05092711 | Unknown DMC FDA Drug

• 1 other identifier: COVIHD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Using INTERASPIRE model to determine patients with established CHD whether the guidelines on cardiovascular disease prevention are being followed or not with incorporation of COVID 19 as a risk factor with the other classical risk factors to understand significance of the new pandemic virus in mortality and morbidity of CVD and coronary events in association with the other known classical risk factors .

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (6)

• • To determine in patients with established CHD (acute myocardial infarction and ischaemia and patients following revascularisation by angioplasty or coronary artery surgery) whether the guidelines on cardiovascular disease prevention are being followed.

  1.5 year

• • To follow-up all patients one year after the interview for hospitalisations, cardiovascular procedures, cardiovascular events and cardiovascular and all cause mortality

  1.5 year

• • To describe the prevalence of cardiovascular risk factors, acute and long-term cardiovascular complications and therapeutic management in patients with CHD and COVID-19

  1.5 year

• • To compare the risk factor profiles in CHD patients with and without a history of COVID-19

  1.5 year

• • To compare the diagnostic and therapeutic strategies in CHD patients with and without a history of COVID-19

  1.5 year

• • To compare the acute and long-term cardiovascular complications in CHD patients with and without a history of COVID-19

  1.5 year

Secondary Outcomes (3)

• • To compare diagnostic and therapeutic strategies in prevalent cases of familial hypercholesterolaemia in patients with established coronary disease and the residual risk among these patients with current treatments.

  1.5 year

• • To compare diagnostic and therapeutic strategies in patients with established coronary disease in relation to glucose metabolism (impaired fasting glycaemia, impaired glucose tolerance and diabetes).

  1.5 year

• • To follow-up all patients one year after the interview for hospitalisations, cardiovascular procedures, cardiovascular events and cardiovascular and all cause mortality

  1.5 year

Study Arms (1)

in patients with coronary heart disease and COVID 19

Behavioral: Observation; Drug: Observation

Interventions

Observation BEHAVIORAL

Using INTERASPIRE model to determine patients with established CHD whether the guidelines on cardiovascular disease prevention are being followed or not with incorporation of COVID 19 as a risk factor with the other classical risk factors to understand significance of the new pandemic virus in mortality and morbidity of CVD and coronary events in association with the other known classical risk factors .

in patients with coronary heart disease and COVID 19

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

will be taken as 150 patients from patients attending Assiut University Heart Hospital outpatient clinic.

You may qualify if:

• consecutive patients, men or women \[≥18 years and \<80 years at the time of identification\]
• Patient s may fulfil more than one of the following diagnostic criteria:
• Elective CABG.
• Elective PCI.
• Acute coronary syndromes (acute myocardial infarction with ST elevation (STEMI) and Non ST elevation MI (Non-STEMI) including those treated with primary PCI and/or CABG, and unstable angina).
• It is recognised that hospital diagnoses for AMI, and unstable angina without evidence of infarction, may not always meet the World Heart Organisation (WHO) or other standard diagnostic criteria. However, it is important to include all cases diagnosed as AMI or unstable angina in hospital clinical practice because, as a consequence of these diagnoses, they should all have received appropriate management for secondary prevention.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mohamed AboelKasem farghal, Professor

  Assiut University

  STUDY DIRECTOR

• Hossam Hassan Ali Elaraby, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Marghany Hassan, Resident

CONTACT

01285006001; ghnofer@Gmail.com

Hossam Hassan Ali Elaraby, Professor

CONTACT

01223971327; hosam_hasan@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Marghany Hassan Mohammed

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 25, 2021
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

EG (1)