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Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE)

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ClinicalTrials.gov Identifier: NCT03781492
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mariusz Gasior, Silesian Centre for Heart Diseases

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.

Condition or disease
Stable Angina Coronary Artery Disease

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective REgistry of Stable Angina manaGEment and Treatment
Actual Study Start Date : January 1, 2006
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina




Primary Outcome Measures :
  1. Number of participants with reported deaths from any cause [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 5 year ]

Secondary Outcome Measures :
  1. Number of participants with reported myocardial infarction [ Time Frame: From date of inclusion until the date of first event, assessed up to 5 year ]
  2. Number of participants with reported cerebrovascular insult [ Time Frame: From date of inclusion until the date of first event, assessed up to 5 year ]
  3. Number of participants with reported acute coronary syndrome driven revascularisation [ Time Frame: From date of inclusion until the date of first event, assessed up to 5 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • symptom based diagnosis of stable angina

Exclusion Criteria:

  • acute coronary syndrome on admission
  • ≤ 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781492


Contacts
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Contact: Piotr Desperak, MD +48514374167 desperak.piotr@gmail.com

Locations
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Poland
3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases Recruiting
Zabrze, Silesia, Poland, 41-800
Contact: Mariusz Gąsior, Prof, MD, PhD         
Sponsors and Collaborators
Silesian Centre for Heart Diseases

Additional Information:

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Responsible Party: Mariusz Gasior, Prof, PhD, MD, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT03781492     History of Changes
Other Study ID Numbers: PRESAGE Registry
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chest Pain
Pain
Coronary Artery Disease
Angina Pectoris
Angina, Stable
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms