Clinical trial NCT04895176: incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS
Official title: incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Heart Failure
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
First posted: 2021-05-20
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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

Primary outcomes:
measure: Incidence of Heart Failure after Acute Coronary Artery Syndrome
timeFrame: 12 month
measure: Identify prognostic markers
timeFrame: 12 month
Secondary outcomes:
measure: The relation between the type of ACS and incidence of HF
timeFrame: 12 month
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: AOU Città della salute e della Scienza
name: Fabrizio D'Ascenzo, MD
role: PRINCIPAL_INVESTIGATOR
References: