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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- 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)
- 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.
- 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 .
- Conditions
- Ischemic Heart Disease
- 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 group | Role | What they receive |
|---|---|---|
| in patients with coronary heart disease and COVID 19 | Not described Receives: Behavioral: Observation; Drug: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
• 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
• 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
• To compare the risk factor profiles in CHD patients with and without a history of COVID-19
Measured: 1.5 year
• To compare the diagnostic and therapeutic strategies in CHD patients with and without a history of COVID-19
Measured: 1.5 year
• 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)
• 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
• 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
• 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.
- First posted25 Oct 2021
- Study start1 Jul 2022
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Marghany Hassan Mohamed, Assiut University
- Investigators
- Mohamed AboelKasem farghal, Professor, Study director, Assiut UniversityHossam Hassan Ali Elaraby, Professor, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors , Complications and Threputic Management Strategies in Patients With Coronary Heart Disease and COVID 19
- ClinicalTrials.gov ID
- NCT05092711
- Acronym / sponsor ID
- COVIHD
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- 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)
- 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.
- 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in patients with coronary heart disease and COVID 19 | – | Behavioral: Observation, Drug: Observation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- will be taken as 150 patients from patients attending Assiut University Heart Hospital outpatient clinic.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationUsing 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 . | Behavioural | in patients with coronary heart disease and COVID 19 |
| ObservationUsing 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 . | Drug | in patients with coronary heart disease and COVID 19 |
Primary outcome
• 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
• To follow-up all patients one year after the interview for hospitalisations, cardiovascular procedures, cardiovascular events and cardiovascular and all cause mortality
Time frame: 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
Time frame: 1.5 year
• To compare the risk factor profiles in CHD patients with and without a history of COVID-19
Time frame: 1.5 year
• To compare the diagnostic and therapeutic strategies in CHD patients with and without a history of COVID-19
Time frame: 1.5 year
• To compare the acute and long-term cardiovascular complications in CHD patients with and without a history of COVID-19
Time frame: 1.5 year
3 secondary outcomes
• 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.
Time frame: 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).
Time frame: 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
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed AboelKasem farghal, Professor study director
Assiut University
Hossam Hassan Ali Elaraby, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
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.