Clinical trial NCT03781492: Stable Angina Management and Treatment
Official title: Prospective REgistry of Stable Angina manaGEment and Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stable Angina
Coronary Artery Disease
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is formed by all-comer patients hospitalized in cardiology ward with a diagnosis of stable angina.

Brief summary: The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an observational study on an all-comer stable angina population hospitalised in a highly specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to assess the clinical characteristics, treatment modalities, early and long-term outcomes in this population.

Detailed description: The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is a single-center, observational study recruiting consecutive patients with stable angina, who were diagnosed and treated in the 3rd Chair and Department of Cardiology in the Silesian Centre for Heart Diseases in Zabrze, Poland. The Silesian Centre for Heart Diseases is a highly specialised cardiology centre with cardiac surgery facilities

The main objective of the PRESAGE Registry is to clarify the overall clinical characteristics of patients with stable angina, their demographics and clinical profile, current management, early and long-term outcomes, with regard to the administered treatment.

The diagnosis of stable angina was based on clinical characterization, coronary angiography, and the current guidelines of the European Society of Cardiology. Patients with vasospastic and/or microvascular angina were also included to the registry. Performance of coronary angiography is the criterion of the enrolment in the registry.

Patients with acute coronary syndromes are excluded from the analysis.

Data collection is patient-based (not event-based).

Complete patient demographics: medical history, complete hospitalization data (diagnostic and therapeutic) and in-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all-cause mortality and major cardiac adverse events.

Eligibility criteria: Inclusion Criteria:

* symptom based diagnosis of stable angina

Exclusion Criteria:

* acute coronary syndrome on admission
* ≤ 18 years old

Primary outcomes:
measure: Number of participants with reported deaths from any cause
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 5 year
Secondary outcomes:
measure: Number of participants with reported myocardial infarction
timeFrame: From date of inclusion until the date of first event, assessed up to 5 year
measure: Number of participants with reported cerebrovascular insult
timeFrame: From date of inclusion until the date of first event, assessed up to 5 year
measure: Number of participants with reported acute coronary syndrome driven revascularisation
timeFrame: From date of inclusion until the date of first event, assessed up to 5 year
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: 3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases
state: Silesia
Study officials:
References: