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Ischemic Heart DiseaseNCT05092711

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

An observational study of Ischemic Heart Disease, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Heart Disease
What is being tested?
Observation
How many people
150 participants
Where
1 siteEgypt
Study dates
1 Jul 2022to Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 150 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ahmed Marghany Hassan, Resident contact

01285006001

ghnofer@Gmail.com

Hossam Hassan Ali Elaraby, Professor contact

01223971327

hosam_hasan@aun.edu.eg

Egypt1 site, 1 recruiting
  • Assuit university

    Asyut

    Recruiting

Other trials in Egypt

About this study

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 .

Read the detailed description

Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels, CVD includes coronary artery diseases (CAD) such as angina and myocardial infarction (commonly known as a heart attack. Other CVDs include stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, abnormal heart rhythms, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease, thromboembolic disease, and venous thrombosis.

At the 65th World Health Assembly in May 2012 Ministers of Health and Senior Health Officials from the 194 WHO member states adopted a global target to reduce premature mortality from non-communicable diseases (NCDs), and in particular cardiovascular disease, by 25% by 2025. The main objectives of CVD prevention are to reduce cardiovascular morbidity and mortality, improve quality of life, and increase life expectancy.

The 52 country INTERHEART study has shown that the classical risk factors for CHD account for most of the risk of myocardial infarction worldwide. This scientific evidence has led to international, regional and national guidelines on CVD prevention, which define patient priorities for preventive action and lifestyle and treatment goals

  1. In 1994, 1998, 2003, 2007, 2012 and 2016. [3-7]. The European Society of Cardiology together with other partner Societies has engaged in a comprehensive programme of CVD prevention in clinical practice since 1994 with the acronym EUROASPIRE (European Action on Secondary and Primary Prevention by Intervention to Reduce Events)
  2. in 2012: Ministers of Health and Senior Health Officials: adopted a global target to reduce premature mortality from non-communicable diseases (NCDs), and in particular cardiovascular disease, by 25% by 2025.
  3. In [2], 2013 : The 52 country INTERHEART study has shown that the classical risk factors for CHD account for most of the risk of myocardial infarction worldwide.

The INTERASPIRE survey began when the ESC Euro Observational Research Programme decided to expand the EUROASPIRE programme to include other WHO regions, starting with a pilot study in Malaysia and Argentina in 2019. The main survey (2020-2022) is now being organised in partnership with the World Heart Federation, Asia Pacific Society of Cardiology, InterAmerican Society of Cardiology and the Pan-African Society of Cardiology and includes selected countries in all 6 WHO regions: African Region, Region of Americas, Eastern Mediterranean Region, European Region, South-East Asia Region, and Western Pacific Region.

  • This international study is being conducted through National Societies of Cardiology which have responsibility for appointing National Coordinators, selecting geographical regions (minimum of three) and hospital centres (minimum of 6 in each country) together with Principal Investigators.
  • The study population is a consecutive sample of coronary patients from each hospital which meet the following diagnostic criteria: Acute coronary syndromes (acute myocardial infarction with ST elevation (STEMI) and Non ST elevation MI (Non-STEMI) and stable coronary artery disease). Patients are interviewed and examined in hospital using standardised methodology, including one central laboratory in Helsinki, Finland, for measurement of fasting lipids, glucose, HbA1c, creatinine and urinary albumin, and then followed up for hospitalisations, non-fatal and fatal cardiovascular events and all cause mortality.

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 .

Being tested
Observation
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationBehavioural

    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 .

  • ObservationDrug

    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 .

Study groups in NCT05092711
Study groupRoleWhat they receive
in patients with coronary heart disease and COVID 19Not described
Receives: Behavioral: Observation; Drug: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • 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.

    Measured: 1.5 year

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

    Measured: 1.5 year

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

    Measured: 1.5 year

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

    Measured: 1.5 year

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

    Measured: 1.5 year

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

    Measured: 1.5 year

Secondary outcomes (3)
  1. • 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.

    Measured: 1.5 year

  2. • 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).

    Measured: 1.5 year

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

    Measured: 1.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start1 Jul 2022
  3. Primary completionMar 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092711
Sponsor's protocol ID
COVIHD
Status last verified
Sep 2022
First submitted
22 Oct 2021
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Marghany Hassan, Resident (01285006001, ghnofer@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• 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. (time frame: 1.5 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.

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