Chronic Coronary Syndrome Snapshot Study (C2S2)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndrome

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Emilie Head of Department; Phone Number: +33489872018; Email: registries@escardio.org
• Study Contact Backup: Name: Carole Clinical Project Manager; Email: registries@escardio.org

Study Locations

• Armenia
  • Yerevan, Armenia
    • Recruiting
    • Erebouni Medical Center
    • Contact: Erebouni Medical Center; Phone Number: +374 91 505005; Email: cardioerebouni@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the follow up visit at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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	From the enrolment and until the end of follow up at 3 months

Collaborators and Investigators

• Sponsor: European Society of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): June 2, 2025
• Study Completion (Estimated): June 2, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Observational study; Chronic Coronary Syndrome; ESC Guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2024-A01053-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No