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Completed

NCT Number: NCT03796741

STable Coronary Artery Diseases RegisTry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection on Stable Ischemic heart disease

Other

No intervention only description of management and treatment

Primary outcomes

  1. 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

  1. Number of patient in optimal medical therapy

    Time frame: 12 months Follow-up

    Patient treated according to International Guidelines

  2. Mortality rate

    Time frame: 12 months Follow-up

    Rate of patients died

  3. All cause hospitalization rate

    Time frame: 12 months Follow-up

    Rate of patients hospitalized

  4. Angina recurrence rate

    Time frame: 12 months Follow-up

    Rate of patients with angina symtoms

Sponsors and collaborators

Lead sponsor

Heart Care Foundation

Other

Registry information

Acronym: START

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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