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Clinical Trials/NCT03796741
NCT03796741
Completed
Not Applicable

STable Coronary Artery Diseases RegisTry

Heart Care Foundation182 sites in 1 country5,070 target enrollmentMarch 17, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Ischemic Heart Disease
Sponsor
Heart Care Foundation
Enrollment
5070
Locations
182
Primary Endpoint
Number of patients in medical therapy and that underwent revascularization
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 17, 2016
End Date
April 24, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heart Care Foundation
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of patients in medical therapy and that underwent revascularization

Time Frame: Enrollment

Number of patients in medical therapy and that underwent revascularization

Secondary Outcomes

  • All cause hospitalization rate(12 months Follow-up)
  • Angina recurrence rate(12 months Follow-up)
  • Number of patient in optimal medical therapy(12 months Follow-up)
  • Mortality rate(12 months Follow-up)

Study Sites (182)

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