Stable Angina Management and Treatment

Coronary Artery Disease Clinical Trial

— PRESAGE  

Official title:

Prospective REgistry of Stable Angina manaGEment and Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781492
• Other study ID #: PRESAGE Registry
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Stable Angina

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