Acute Coronary SyndromeCORALYSNCT04895176
incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS
An observational study of Acute Coronary Syndrome and Heart Failure, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline EF > 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up
Who may be able to join
- • Informed consent
- Age ≥ 18 years
- Previous acute coronary syndrome with percutaneous coronary revascularization
- Baseline EF > 40%
- At least 12 months of follow-up
Who cannot join
- • Significant valvular heart disease (greater than mild stenosis or moderate regurgitation) before ACS
- Type 1, 3, 4, 5 pulmonary hypertension (14) before ACS
- Constrictive pericarditis before ACS
- Primary or infiltrative cardiomyopathies
- Heart transplantation
- Medical therapy with loop diuretics for heart failure before ACS
- Previous hospitalizations for heart failure or clinical sign of heart failure detected outpatient before ACS
Trial locations and contacts
1 site in 1 country.
About this study
Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention
Read the detailed description
Acute coronary syndrome (ACS) is the most common cause of heart failure (HF) world-wide. Primary percutaneous coronary intervention (PCI) has deeply improved short and long-term survival after ACS, but his impact on incidence of downstream heart failure still remains unclear and heart failure after ACS represents the major driver of late morbidity, mortality and healthcare cost.
Many predictors and determinant of heart failure after MI have been evaluated, however, to date, the optimal combination of parameters to predict heart failure after MI needs to be defined and very little is known about the prognostic markers in unstable angina setting
The aim of this retrospective study:
- to show the incidence of heart failure after acute coronary artery syndrome, and the relation between the type of ACS and following incidence of HF.
- to clarify which features could be routinely identified as prognostic markers. This study is a multi-center non-randomized, single-cohort retrospective study including consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline EF > 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up.
It is possible to anticipate that the main findings of the present study will fill fundamental knowledge gaps regarding incidence of heart failure following coronary events.
Among this, the study could suggest specific clinical and epidemiological features related to the risk of development of HF, leading to a better medical treatment and reducing risk for further hospitalizations.
- Conditions
- Acute Coronary Syndrome, Heart Failure
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Heart Failure after Acute Coronary Artery Syndrome
To show the incidence of heart failure after acute coronary artery syndrome.
Measured: 12 month
Identify prognostic markers
To clarify which features could be routinely identified as prognostic markers in this setting
Measured: 12 month
Secondary outcomes (1)
The relation between the type of ACS and incidence of HF
the relation between the type of ACS and following incidence of HF will be investigated
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
- Investigators
- Fabrizio D'Ascenzo, MD, Principal investigator, AOU Città della salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895176
- Sponsor's protocol ID
- CORALYS
- Acronym
- CORALYS
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Ascenzo F, Fabris E, DeGregorio C, Mittone G, De Filippo O, Wanha W, Leonardi S, Roubin SR, Chinaglia A, Truffa A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Pagliaro B, Nunez-Gil IJ, Ugo F, Marengo G, Barbieri L, Marchini F, Desperak P, Melendo-Viu M, Montalto C, Bianco M, Bruno F, Mancone M, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu Assi E, Stefanini G, Sinagra G, de Ferrari GM. Forecasting the Risk of Heart Failure Hospitalization After Acute Coronary Syndromes: the CORALYS HF Score. Am J Cardiol. 2023 Nov 1;206:320-329. doi: 10.1016/j.amjcard.2023.08.010. Epub 2023 Sep 19.
PubMed 37734293Bruno F, Marengo G, De Filippo O, Wanha W, Leonardi S, Raposeiras Roubin S, Fabris E, Popovic M, Giannino G, Truffa A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Nunez-Gil IJ, Melis D, Ugo F, Bianco M, Barbieri L, Marchini F, Desperak P, Montalto C, Melendo-Viu M, Elia E, Mancone M, Buono A, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Sardella G, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu-Assi E, Sinagra G, De Ferrari GM, D'Ascenzo F; Collaborators. Impact of Complete Revascularization on Development of Heart Failure in Patients With Acute Coronary Syndrome and Multivessel Disease: A Subanalysis of the CORALYS Registry. J Am Heart Assoc. 2023 Aug;12(15):e028475. doi: 10.1161/JAHA.122.028475. Epub 2023 Jul 25.
PubMed 37489724
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS
- ClinicalTrials.gov ID
- NCT04895176
- Acronym / sponsor ID
- CORALYS / CORALYS
- Conditions
- Acute Coronary Syndrome, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- University of Turin, Italy
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 20 May 2021 (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.
Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention
Detailed description
Acute coronary syndrome (ACS) is the most common cause of heart failure (HF) world-wide. Primary percutaneous coronary intervention (PCI) has deeply improved short and long-term survival after ACS, but his impact on incidence of downstream heart failure still remains unclear and heart failure after ACS represents the major driver of late morbidity, mortality and healthcare cost.
Many predictors and determinant of heart failure after MI have been evaluated, however, to date, the optimal combination of parameters to predict heart failure after MI needs to be defined and very little is known about the prognostic markers in unstable angina setting
The aim of this retrospective study:
- to show the incidence of heart failure after acute coronary artery syndrome, and the relation between the type of ACS and following incidence of HF.
- to clarify which features could be routinely identified as prognostic markers. This study is a multi-center non-randomized, single-cohort retrospective study including consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline EF > 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up.
It is possible to anticipate that the main findings of the present study will fill fundamental knowledge gaps regarding incidence of heart failure following coronary events.
Among this, the study could suggest specific clinical and epidemiological features related to the risk of development of HF, leading to a better medical treatment and reducing risk for further hospitalizations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline EF > 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up
Key inclusion criteria (5 listed)
- • Informed consent
Key exclusion criteria (7 listed)
- • Significant valvular heart disease (greater than mild stenosis or moderate regurgitation) before ACS
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
Incidence of Heart Failure after Acute Coronary Artery Syndrome
Time frame: 12 month
To show the incidence of heart failure after acute coronary artery syndrome.
Identify prognostic markers
Time frame: 12 month
To clarify which features could be routinely identified as prognostic markers in this setting
1 secondary outcome
The relation between the type of ACS and incidence of HF
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Derived from this study: PubMed 37734293D'Ascenzo F, Fabris E, DeGregorio C, Mittone G, De Filippo O, Wanha W, Leonardi S, Roubin SR, Chinaglia A, Truffa A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Pagliaro B, Nunez-Gil IJ, Ugo F, Marengo G, Barbieri L, Marchini F, Desperak P, Melendo-Viu M, Montalto C, Bianco M, Bruno F, Mancone M, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu Assi E, Stefanini G, Sinagra G, de Ferrari GM. Forecasting the Risk of Heart Failure Hospitalization After Acute Coronary Syndromes: the CORALYS HF Score. Am J Cardiol. 2023 Nov 1;206:320-329. doi: 10.1016/j.amjcard.2023.08.010. Epub 2023 Sep 19.
- Derived from this study: PubMed 37489724Bruno F, Marengo G, De Filippo O, Wanha W, Leonardi S, Raposeiras Roubin S, Fabris E, Popovic M, Giannino G, Truffa A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Nunez-Gil IJ, Melis D, Ugo F, Bianco M, Barbieri L, Marchini F, Desperak P, Montalto C, Melendo-Viu M, Elia E, Mancone M, Buono A, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Sardella G, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu-Assi E, Sinagra G, De Ferrari GM, D'Ascenzo F; Collaborators. Impact of Complete Revascularization on Development of Heart Failure in Patients With Acute Coronary Syndrome and Multivessel Disease: A Subanalysis of the CORALYS Registry. J Am Heart Assoc. 2023 Aug;12(15):e028475. doi: 10.1161/JAHA.122.028475. Epub 2023 Jul 25.
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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. This study is not recruiting at the moment.
Fabrizio D'Ascenzo, MD principal investigator
AOU Città della salute e della Scienza
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 Acute Coronary Syndrome and Heart Failure, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 May 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio D'Ascenzo, MD (0039 011 633 6023, fabrizio.dascenzo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Heart Failure after Acute Coronary Artery Syndrome (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04895176, which also lists 2 linked publications.
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 20 May 2021.