Stable AnginaPRESAGENCT03781492
Stable Angina Management and Treatment
An observational study of Stable Angina and Coronary Artery Disease, run by Silesian Centre for Heart Diseases at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Coronary Artery Disease
- How many people
- 25,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2006to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population is formed by all-comer patients hospitalized in cardiology ward with a diagnosis of stable angina.
Who may be able to join
- symptom based diagnosis of stable angina
Who cannot join
- acute coronary syndrome on admission
- ≤ 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases
Zabrze, Silesian Voivodeship, 41-800
Mariusz Gąsior, Prof, MD, PhD
About this study
Official title: Prospective REgistry of Stable Angina manaGEment and Treatment
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.
Read the 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.
- Conditions
- Stable Angina, Coronary Artery Disease
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reported deaths from any cause
Measured: From date of inclusion until the date of death from any cause, assessed up to 5 year
Secondary outcomes (3)
Number of participants with reported myocardial infarction
Measured: From date of inclusion until the date of first event, assessed up to 5 year
Number of participants with reported cerebrovascular insult
Measured: From date of inclusion until the date of first event, assessed up to 5 year
Number of participants with reported acute coronary syndrome driven revascularisation
Measured: From date of inclusion until the date of first event, assessed up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Gasior, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781492
- Sponsor's protocol ID
- PRESAGE Registry
- Acronym
- PRESAGE
- Status last verified
- May 2020
- First submitted
- 18 Dec 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective REgistry of Stable Angina manaGEment and Treatment
- ClinicalTrials.gov ID
- NCT03781492
- Acronym / sponsor ID
- PRESAGE / PRESAGE Registry
- Conditions
- Stable Angina, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is formed by all-comer patients hospitalized in cardiology ward with a diagnosis of stable angina.
Key inclusion criteria (1 listed)
- symptom based diagnosis of stable angina
Key exclusion criteria (2 listed)
- acute coronary syndrome on admission
- ≤ 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Number of participants with reported myocardial infarction
Time frame: From date of inclusion until the date of first event, assessed up to 5 year
Number of participants with reported cerebrovascular insult
Time frame: From date of inclusion until the date of first event, assessed up to 5 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Coronary Artery Disease, run by Silesian Centre for Heart Diseases at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Desperak, MD (+48514374167, desperak.piotr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.