NCT06748924

Brief 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 (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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 19, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Observational studyESC GuidelinesChronic Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Assess Variations in Adherence Across Healthcare Settings

    From the enrolment and until the follow up visit at 3 months

  • Analyse Regional Variations

    From the enrolment and until the follow up visit at 3 months

  • Examine Disparities in Guideline Adherence

    From the enrolment and until the follow up 3 months

  • Identify Potential Barriers and Facilitators to Guideline Implementation

    From the enrolment and until the follow up 3 months

  • Equitable access to cardiovascular care

    From the enrolment and until the end of follow up at 3 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erebouni Medical Center

Yerevan, Armenia

RECRUITING

Central Study Contacts

Emilie Head of Department

CONTACT

Carole Clinical Project Manager

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

December 2, 2024

Primary Completion

June 2, 2025

Study Completion

June 2, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations