incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS

NCT ID: NCT04895176

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-06-30

Brief Summary

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Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention

Detailed Description

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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

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Acute Coronary Syndrome Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* • Informed consent

* Age ≥ 18 years
* Previous acute coronary syndrome with percutaneous coronary revascularization
* Baseline EF \> 40%
* At least 12 months of follow-up

Exclusion Criteria

* • 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role collaborator

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

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Fabrizio D'Ascenzo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabrizio D'Ascenzo, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della salute e della Scienza

Locations

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AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

Countries

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Italy

Central Contacts

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Fabrizio D'Ascenzo, MD

Role: CONTACT

0039 011 633 6023

References

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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.

Reference Type DERIVED
PMID: 37734293 (View on PubMed)

Bruno 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.

Reference Type DERIVED
PMID: 37489724 (View on PubMed)

Other Identifiers

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CORALYS

Identifier Type: -

Identifier Source: org_study_id

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