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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03781492
Other study ID # PRESAGE Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date December 31, 2026

Study information

Verified date May 2020
Source Silesian Centre for Heart Diseases
Contact Piotr Desperak, MD
Phone +48514374167
Email desperak.piotr@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- symptom based diagnosis of stable angina

Exclusion Criteria:

- acute coronary syndrome on admission

- = 18 years old

Study Design


Locations

Country Name City State
Poland 3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases Zabrze Silesia

Sponsors (1)

Lead Sponsor Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with reported deaths from any cause From date of inclusion until the date of death from any cause, assessed up to 5 year
Secondary Number of participants with reported myocardial infarction From date of inclusion until the date of first event, assessed up to 5 year
Secondary Number of participants with reported cerebrovascular insult From date of inclusion until the date of first event, assessed up to 5 year
Secondary Number of participants with reported acute coronary syndrome driven revascularisation From date of inclusion until the date of first event, assessed up to 5 year
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