Coronary Arterial Disease (CAD)NCT06684366
Chronic Coronary Syndrome Real Practice and Guidelines
An observational study of Coronary Arterial Disease (CAD), run by Assiut University at 1 site in Egypt.
Trial summary
Evaluate Adherence to the 2019 ESC Guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Statins (atorvastatin or simvastatin)
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2024to 22 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina and/or dyspnea, and suspected coronary artery disease. Patients with new onset of heart failure or reduced left ventricular function. Patients within 1 year after an acute coronary syndrome or recent revascularization. Patients beyond 1 year after initial diagnosis or revascularization. Patients with ANOCA (e.g., microvascular angina, vasospastic angina). Asymptomatic subjects referred for screening for coronary artery disease.
Who may be able to join
- Adult patients (18 years or older) with a confirmed or suspected diagnosis of CCS, fall within one of the following broad CCS categories:
- Patients with angina and/or dyspnea, and suspected coronary artery disease.
- Patients with new onset of heart failure or reduced left ventricular function.
- Patients within 1 year after an acute coronary syndrome or recent revascularization.
- Patients beyond 1 year after initial diagnosis or revascularization.
- Patients with ANOCA (e.g., microvascular angina, vasospastic angina).
- Asymptomatic subjects referred for screening for coronary artery disease.
Who cannot join
- Patients with a recent acute coronary syndrome (defined as those within 1 month of a diagnosis of unstable angina, non-ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Coronary Syndrome...real Practice and Guidelines...A Single Center Registery
Evaluate Adherence to the 2019 ESC Guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center
Read the detailed description
Coronary artery disease (CAD) refers to the presence of atherosclerotic plaques in the coronary arteries, Which can be non-obstructive or obstructive. It represents a major cause of morbidity, mortality, Hospitalization and health expenditure.
The most recent European Guidelines for the diagnosis and management of CCS delineate six common CCS scenarios: patients with suspected CAD and stable angina symptoms and/or dyspnea; patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; asymptomatic and symptomatic patients with stabilized symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; Patients with angina and suspected vasospastic or microvascular disease; Asymptomatic subjects in whom CAD is detected at screening. Although these scenarios are heterogeneous, they are associated with an increased risk of acute events, and the stability of CCS patients over time depends on prompt diagnosis, optimal treatment and secondary prevention strategies, including Lifestyle modifications, and pharmacotherapy.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Statins (atorvastatin or simvastatin)
- Keywords
- chronic coronary syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statins (atorvastatin or simvastatin)Drug
A resting transthoracic echocardiogram Non-invasive functional imaging for myocardial ischemia or coronary computed tomography angiography (CCTA) is recommended as the initial test for diagnosing CAD in symptomatic patients in whom obstructive CAD cannot be excluded by clinical assessment alone
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of revasculariztion strategies on chronic coronary syndrome patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 Oct 2024
- Primary completion22 Oct 2025 (estimated)
- Study completion22 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Gad Bayoumi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684366
- Sponsor's protocol ID
- Chronic coronary Syndrome
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Coronary Syndrome...real Practice and Guidelines...A Single Center Registery
- ClinicalTrials.gov ID
- NCT06684366
- Acronym / sponsor ID
- Chronic coronary Syndrome
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- chronic coronary syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 22 Oct 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
Evaluate Adherence to the 2019 ESC Guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center
Detailed description
Coronary artery disease (CAD) refers to the presence of atherosclerotic plaques in the coronary arteries, Which can be non-obstructive or obstructive. It represents a major cause of morbidity, mortality, Hospitalization and health expenditure.
The most recent European Guidelines for the diagnosis and management of CCS delineate six common CCS scenarios: patients with suspected CAD and stable angina symptoms and/or dyspnea; patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; asymptomatic and symptomatic patients with stabilized symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; Patients with angina and suspected vasospastic or microvascular disease; Asymptomatic subjects in whom CAD is detected at screening. Although these scenarios are heterogeneous, they are associated with an increased risk of acute events, and the stability of CCS patients over time depends on prompt diagnosis, optimal treatment and secondary prevention strategies, including Lifestyle modifications, and pharmacotherapy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina and/or dyspnea, and suspected coronary artery disease. Patients with new onset of heart failure or reduced left ventricular function. Patients within 1 year after an acute coronary syndrome or recent revascularization. Patients beyond 1 year after initial diagnosis or revascularization. Patients with ANOCA (e.g., microvascular angina, vasospastic angina). Asymptomatic subjects referred for screening for coronary artery disease.
Key inclusion criteria (7 listed)
- Adult patients (18 years or older) with a confirmed or suspected diagnosis of CCS, fall within one of the following broad CCS categories:
- Patients with angina and/or dyspnea, and suspected coronary artery disease.
- Patients with new onset of heart failure or reduced left ventricular function.
- Patients within 1 year after an acute coronary syndrome or recent revascularization.
- Patients beyond 1 year after initial diagnosis or revascularization.
Key exclusion criteria (1 listed)
- Patients with a recent acute coronary syndrome (defined as those within 1 month of a diagnosis of unstable angina, non-ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
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 |
|---|---|---|
| Statins (atorvastatin or simvastatin)A resting transthoracic echocardiogram Non-invasive functional imaging for myocardial ischemia or coronary computed tomography angiography (CCTA) is recommended as the initial test for diagnosing CAD in symptomatic patients in whom obstructive CAD cannot be excluded by clinical assessment alone | Drug | – |
Primary outcome
effect of revasculariztion strategies on chronic coronary syndrome patients
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Arterial Disease (CAD), 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of revasculariztion strategies on chronic coronary syndrome patients (time frame: 6 months). 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 12 Nov 2024.