Chronic Coronary SyndromeC2S2NCT06748924
Chronic Coronary Syndrome Snapshot Study
An observational study of Chronic Coronary Syndrome, run by European Society of Cardiology at 1 site in Armenia.
Trial summary
The goal of this observational study is to evaluate the current adherence to the 2019 European Society of Cardiology (ESC) Guidelines on Chronic Coronary Syndrome among healthcare professionals and identify potential barriers and facilitators to guideline implementation in patients with Chronic Coronary Syndrome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 4,000 participants
- Where
- 1 siteArmenia
- Study dates
- 2 Dec 2024to 2 Jun 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: The study will include patients who align with the criteria set by the 2019 ESC Guidelines on CCS and that have been receiving medical care in accordance with these guidelines across 5 broad CCS categories: i) patients with angina and/or dyspnoea, and suspected coronary artery disease; ii) patients with new onset of heart failure or reduced left ventricular function; iii) patients with a long-standing diagnosis of CCS (i.e., those with stabilized symptoms <1 year after an acute coronary syndrome or with recent revascularization, and those >1 year after initial diagnosis or revascularization); iv) patients with angina without obstructive disease in the epicardial coronary arteries (i.e., microvascular angina, vasospastic angina); v) asymptomatic subjects referred to screening for coronary artery disease.
Who may be able to join
- Patients with angina and/or dyspnoea, 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 revascularisation.
- Patients beyond 1 year after initial diagnosis or revascularisation.
- Patients with Angina with No Obstructive Coronary Artery disease (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).
- Patients with conditions unrelated to CCS that significantly limit their ability to participate in the study or interfere with the assessment of guideline adherence.
- Patients participating in any clinical study where the protocol recommends deviations from guidelines recommendations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carole Clinical Project Manager contact
Armenia1 site, 1 recruiting
- Recruiting
Erebouni Medical Center
Yerevan
Erebouni Medical Center, +374 91 505005, cardioerebouni@yahoo.com
About this study
The goal of this observational study is to evaluate the current adherence to the 2019 European Society of Cardiology (ESC) Guidelines on Chronic Coronary Syndrome among healthcare professionals and identify potential barriers and facilitators to guideline implementation in patients with Chronic Coronary Syndrome (CCS). The main questions it aims to answer are:
AIM 1 - Evaluate Adherence to the 2019 ESC Guidelines on CCS Among Healthcare Professionals: To comprehensively assess the extent to which healthcare professionals adhere to the 2019 ESC Guidelines on CCS. • SUB AIM 1.1 - Assess Variations in Adherence Across Healthcare Settings: Identifying variations in adherence patterns across different healthcare settings (e.g., primary care clinics, specialty hospitals, and other healthcare facilities) to shed light on the impact of resource availability on guideline implementation.
Read more
- SUB AIM 1.2 - Analyse Regional Variations: Identifying variations in adherence patterns across different countries or regions, to provide insights into the influence of healthcare systems, cultural factors, and regional disparities on guideline adherence.
- SUB AIM 1.3 - Examine Disparities in Guideline Adherence: Identifying variations in adherence patterns among different demographic groups of healthcare professionals, including gender, age, years of experience, and specialty, to shed light on potential inequities in guideline implementation and help tailor interventions accordingly.
AIM 2 - Identify Potential Barriers and Facilitators to Guideline Implementation:
Through data analysis, we aim to identify potential barriers that hinder guideline implementation and facilitators that promote adherence and offer actionable insights for improvement. These barriers and facilitators may encompass a wide range of factors, including knowledge gaps, resource limitations, organizational constraints, and patient-related variables.
- SUB AIM 2.1 - Equitable access to cardiovascular care: Identifying variations in adherence patterns across sex and ethnicity categories, with a special focus on minorities.
Participants will not have more interventions than their usual care.
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 in Europe.
The European Society of Cardiology (ESC) plays a pivotal role in advancing the field of cardiology by regularly updating and disseminating clinical practice guidelines. In 2019, the ESC released the latest iteration of its guidelines for the diagnosis and management of Chronic Coronary Sydrome (CCS).
The Chronic Coronary Syndrome Snapshot (C2S2) study aims to evaluate the current adherence to the 2019 ESC Guidelines on CCS among healthcare professionals and identify potential barriers and facilitators to guideline implementation.
The results can inform targeted interventions and educational programs aimed at enhancing adherence to the 2019 ESC guidelines for CCS, ultimately improving patient outcomes and the quality of care for individuals with CCS.
C2S2 will enrol adult patients who sign a written informed consent form and with confirmed or suspected diagnosis of CCS amoung these 6 following CCS categories: i) patients with suspected CAD and stable anginal symptoms and/or dyspnoea; ii) patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; iii) asymptomatic and symptomatic patients with stabilised symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; iv) asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; v) patients with angina and suspected vasospastic or microvascular disease; vi) asymptomatic subjects in whom CAD is detected at screening To ensure the representativeness of all the potential healthcare settings, not only hospitals but also outpatient clinics, primary care practices, and healthcare providers in the community will be involved.
The study is designed with 2 visits: one at enrollment and one follow up visit at 3 months to assess the current practice.
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Observational study, ESC Guidelines, Chronic Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Coronary Syndrome | The study will include patients who align with the criteria set by the 2019 ESC Guidelines on CCS and that have been receiving medical care in accordance with these guidelines across 5 broad CCS categories: i) patients with angina and/or dyspnoea, and suspected coronary artery disease; ii) patients with new onset of heart failure or reduced left ventricular function; iii) patients with a long-standing diagnosis of CCS (i.e., those with stabilized symptoms <1 year after an acute coronary syndrome or with recent revascularization, and those >1 year after initial diagnosis or revascularization); iv) patients with angina without obstructive disease in the epicardial coronary arteries (i.e., microvascular angina, vasospastic angina); v) asymptomatic subjects referred to screening for coronary artery disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Adherence to the 2019 ESC Guidelines
Evaluate Adherence to the 2019 ESC Guidelines on CCS Among Healthcare Professionals: To comprehensively assess the extent to which healthcare professionals adhere to the 2019 ESC Guidelines on CCS
Measured: From enrollment to the follow up visit at 3 months
Secondary outcomes (5)
Assess Variations in Adherence Across Healthcare Settings
Identifying variations in adherence patterns across different healthcare settings (e.g., primary care clinics, specialty hospitals, and other healthcare facilities) to shed light on the impact of resource availability on guideline implementation
Measured: From the enrolment and until the follow up visit at 3 months
Analyse Regional Variations
Identifying variations in adherence patterns across different countries or regions, to provide insights into the influence of healthcare systems, cultural factors, and regional disparities on guideline adherence.
Measured: From the enrolment and until the follow up visit at 3 months
Examine Disparities in Guideline Adherence
Identifying variations in adherence patterns among different demographic groups of healthcare professionals, including gender, age, years of experience, and specialty, to shed light on potential inequities in guideline implementation and help tailor interventions accordingly.
Measured: From the enrolment and until the follow up 3 months
Identify Potential Barriers and Facilitators to Guideline Implementation
Through data analysis, we aim to identify potential barriers that hinder guideline implementation and facilitators that promote adherence and offer actionable insights for improvement. These barriers and facilitators may encompass a wide range of factors, including knowledge gaps, resource limitations, organizational constraints, and patient-related variables.
Measured: From the enrolment and until the follow up 3 months
Equitable access to cardiovascular care
Identifying variations in adherence patterns across sex and ethnicity categories, with a special focus on minorities
Measured: From the enrolment and until the end of follow up at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start2 Dec 2024
- Primary completion2 Jun 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society of Cardiology
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748924
- Sponsor's protocol ID
- 2024-A01053-44
- Acronym
- C2S2
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Coronary Syndrome Snapshot Study
- ClinicalTrials.gov ID
- NCT06748924
- Acronym / sponsor ID
- C2S2 / 2024-A01053-44
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Observational study, ESC Guidelines, Chronic Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- European Society of CardiologyResearch network
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 27 Dec 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.
The goal of this observational study is to evaluate the current adherence to the 2019 European Society of Cardiology (ESC) Guidelines on Chronic Coronary Syndrome among healthcare professionals and identify potential barriers and facilitators to guideline implementation in patients with Chronic Coronary Syndrome (CCS). The main questions it aims to answer are:
AIM 1 - Evaluate Adherence to the 2019 ESC Guidelines on CCS Among Healthcare Professionals: To comprehensively assess the extent to which healthcare professionals adhere to the 2019 ESC Guidelines on CCS. • SUB AIM 1.1 - Assess Variations in Adherence Across Healthcare Settings: Identifying variations in adherence patterns across different healthcare settings (e.g., primary care clinics, specialty hospitals, and other healthcare facilities) to shed light on the impact of resource availability on guideline implementation.
- SUB AIM 1.2 - Analyse Regional Variations: Identifying variations in adherence patterns across different countries or regions, to provide insights into the influence of healthcare systems, cultural factors, and regional disparities on guideline adherence.
- SUB AIM 1.3 - Examine Disparities in Guideline Adherence: Identifying variations in adherence patterns among different demographic groups of healthcare professionals, including gender, age, years of experience, and specialty, to shed light on potential inequities in guideline implementation and help tailor interventions accordingly.
AIM 2 - Identify Potential Barriers and Facilitators to Guideline Implementation:
Through data analysis, we aim to identify potential barriers that hinder guideline implementation and facilitators that promote adherence and offer actionable insights for improvement. These barriers and facilitators may encompass a wide range of factors, including knowledge gaps, resource limitations, organizational constraints, and patient-related variables.
- SUB AIM 2.1 - Equitable access to cardiovascular care: Identifying variations in adherence patterns across sex and ethnicity categories, with a special focus on minorities.
Participants will not have more interventions than their usual care.
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 in Europe.
The European Society of Cardiology (ESC) plays a pivotal role in advancing the field of cardiology by regularly updating and disseminating clinical practice guidelines. In 2019, the ESC released the latest iteration of its guidelines for the diagnosis and management of Chronic Coronary Sydrome (CCS).
The Chronic Coronary Syndrome Snapshot (C2S2) study aims to evaluate the current adherence to the 2019 ESC Guidelines on CCS among healthcare professionals and identify potential barriers and facilitators to guideline implementation.
The results can inform targeted interventions and educational programs aimed at enhancing adherence to the 2019 ESC guidelines for CCS, ultimately improving patient outcomes and the quality of care for individuals with CCS.
C2S2 will enrol adult patients who sign a written informed consent form and with confirmed or suspected diagnosis of CCS amoung these 6 following CCS categories: i) patients with suspected CAD and stable anginal symptoms and/or dyspnoea; ii) patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; iii) asymptomatic and symptomatic patients with stabilised symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; iv) asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; v) patients with angina and suspected vasospastic or microvascular disease; vi) asymptomatic subjects in whom CAD is detected at screening To ensure the representativeness of all the potential healthcare settings, not only hospitals but also outpatient clinics, primary care practices, and healthcare providers in the community will be involved.
The study is designed with 2 visits: one at enrollment and one follow up visit at 3 months to assess the current practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Coronary Syndrome | – | –The study will include patients who align with the criteria set by the 2019 ESC Guidelines on CCS and that have been receiving medical care in accordance with these guidelines across 5 broad CCS categories: i) patients with angina and/or dyspnoea, and suspected coronary artery disease; ii) patients with new onset of heart failure or reduced left ventricular function; iii) patients with a long-standing diagnosis of CCS (i.e., those with stabilized symptoms <1 year after an acute coronary syndrome or with recent revascularization, and those >1 year after initial diagnosis or revascularization); iv) patients with angina without obstructive disease in the epicardial coronary arteries (i.e., microvascular angina, vasospastic angina); v) asymptomatic subjects referred to screening for coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients who align with the criteria set by the 2019 ESC Guidelines on CCS and that have been receiving medical care in accordance with these guidelines across 5 broad CCS categories: i) patients with angina and/or dyspnoea, and suspected coronary artery disease; ii) patients with new onset of heart failure or reduced left ventricular function; iii) patients with a long-standing diagnosis of CCS (i.e., those with stabilized symptoms <1 year after an acute coronary syndrome or with recent revascularization, and those >1 year after initial diagnosis or revascularization); iv) patients with angina without obstructive disease in the epicardial coronary arteries (i.e., microvascular angina, vasospastic angina); v) asymptomatic subjects referred to screening for coronary artery disease.
Key inclusion criteria (6 listed)
- Patients with angina and/or dyspnoea, 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 revascularisation.
- Patients beyond 1 year after initial diagnosis or revascularisation.
- Patients with Angina with No Obstructive Coronary Artery disease (ANOCA)(e.g., microvascular angina, vasospastic angina).
Key exclusion criteria (3 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).
- Patients with conditions unrelated to CCS that significantly limit their ability to participate in the study or interfere with the assessment of guideline adherence.
- Patients participating in any clinical study where the protocol recommends deviations from guidelines recommendations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate Adherence to the 2019 ESC Guidelines
Time frame: From enrollment to the follow up visit at 3 months
Evaluate Adherence to the 2019 ESC Guidelines on CCS Among Healthcare Professionals: To comprehensively assess the extent to which healthcare professionals adhere to the 2019 ESC Guidelines on CCS
5 secondary outcomes
Assess Variations in Adherence Across Healthcare Settings
Time frame: From the enrolment and until the follow up visit at 3 months
Analyse Regional Variations
Time frame: From the enrolment and until the follow up visit at 3 months
Examine Disparities in Guideline Adherence
Time frame: From the enrolment and until the follow up 3 months
Identify Potential Barriers and Facilitators to Guideline Implementation
Time frame: From the enrolment and until the follow up 3 months
Equitable access to cardiovascular care
Time frame: From the enrolment and until the end of follow up at 3 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 9 Jan 2025.
- 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.
Carole Clinical Project Manager contact
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 Chronic Coronary Syndrome, run by European Society of Cardiology at 1 site in Armenia.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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 Armenia. 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?
Contact Emilie Head of Department (+33489872018, registries@escardio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Adherence to the 2019 ESC Guidelines (time frame: From enrollment to the follow up visit at 3 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 9 Jan 2025.