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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Acute Coronary Syndrome

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Fabrizio D'Ascenzo, MD; Phone Number: 0039 011 633 6023; Email: fabrizio.dascenzo@gmail.com

Study Locations

• Italy
  • Torino, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Heart Failure after Acute Coronary Artery Syndrome	To show the incidence of heart failure after acute coronary artery syndrome.	12 month
Identify prognostic markers	To clarify which features could be routinely identified as prognostic markers in this setting	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 month

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Collaborators: University of Turin, Italy
• Investigators: Principal Investigator: Fabrizio D'Ascenzo, MD, AOU Città della salute e della scienza

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Heart Failure; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CORALYS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No