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Clinical Trials/NCT04895176
NCT04895176
Unknown
Not Applicable

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

A.O.U. Città della Salute e della Scienza1 site in 1 country10,000 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
A.O.U. Città della Salute e della Scienza
Enrollment
10000
Locations
1
Primary Endpoint
Incidence of Heart Failure after Acute Coronary Artery Syndrome
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
A.O.U. Città della Salute e della Scienza
Responsible Party
Principal Investigator
Principal Investigator

Fabrizio D'Ascenzo

Principal Investigator

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The relation between the type of ACS and incidence of HF(12 month)

Study Sites (1)

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