STable Coronary Artery Diseases RegisTry

Completed

• Conditions: Chronic Ischemic Heart Disease

• Registration Number: NCT03796741
• Lead Sponsor: Heart Care Foundation

Brief Summary

Observational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in Italian cardiology centers.

Detailed Description

Coronary heart disease is still highly prevalent in the world, and chronic stable angina is one of the most common clinical presentations of this disease. The objectives of chronic stable angina treatment include the reduction of symptoms, the inhibition or slowing of the progression of the disease, the prevention of associated cardiovascular events such as myocardial infarction, and the possible improvement of survival.The results of COURAGE Study and of meta-analysis of more recent studies demonstrate that patients in optimized medical therapy (OMT) (aspirin, beta-blocker and statin in association with an ACE-inhibitor and strict control of risk factors). ) the percutaneous coronary revascularization procedure (PCI) did not lead to an improvement in the cardiovascular prognosis. These data led the groups in charge of drafting the guidelines to recommend OMT as an initial treatment of stable angina, reserving the revascularization procedure for those patients with symptoms not adequately controlled by medical therapy.

It is therefore considered appropriate to plan a registry in patients with stable coronary artery disease that has the ability to describe in the heterogeneity of Italian cardiological centers the current characteristics of these patients, their treatment modalities, adherence to the current guidelines both as regards invasive therapy that the optimized medical, the use and the total cost of the resources needed to manage this pathology, the clinical course one year after entering the register.

Consecutive patients discharged (after an ordinary or day hospital admission) or managed as outpatient at Cardiology department participating in the project with a diagnosis of stable coronary artery disease will be included in the register. Enrollment will last 3 months in each center, starting with the first enrolled patient, or up to 50 patients enrolled.

Study Timeline

• Study Start: 2016-03-17
• Primary Completion: 2018-02-28
• Study Completion: 2018-04-24
• Status Verified: 2018-12
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5070

Inclusion Criteria

• Patients aged >/= 18
• Patients discharged from hospital or ambulatory visit with a diagnoses of stable heart disease;
• Written informed consent

Exclusion Criteria

• Acute coronary syndrome within 30 days from enrollment
• CCS Angina Class IV
• Angina probably not for coronary artery disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients in medical therapy and that underwent revascularization	Enrollment	Number of patients in medical therapy and that underwent revascularization

Secondary Outcome Measures

Name	Time	Method
Angina recurrence rate	12 months Follow-up	Rate of patients with angina symtoms
Number of patient in optimal medical therapy	12 months Follow-up	Patient treated according to International Guidelines
Mortality rate	12 months Follow-up	Rate of patients died
All cause hospitalization rate	12 months Follow-up	Rate of patients hospitalized

Trial Locations

Locations (182)

Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic; 🇮🇹 Agrigento, AG, Italy

Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia; 🇮🇹 Ancona, AN, Italy

Ospedale Civile Profili - U.O. Cardiologia; 🇮🇹 Fabriano, AN, Italy

Ospedale Di Jesi Carlo Urbani - U.O. Di Cardiologia; 🇮🇹 Jesi, AN, Italy

Ospedale Principe Di Piemonte - Uoc Cardiologia Utic; 🇮🇹 Senigallia, AN, Italy

Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia; 🇮🇹 Ascoli Piceno, AP, Italy

Ospedale Madonna Del Soccorso - Uoc Cardiologia Indirizzo Riabilitativo; 🇮🇹 San Benedetto Del Tronto, AP, Italy

Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu; 🇮🇹 Cortona, AR, Italy

Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'; 🇮🇹 Avellino, AV, Italy

Ospedale San Paolo - Cardiologia-Utic; 🇮🇹 Bari, BA, Italy

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