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

Heart Failure Clinical Trial

— CORALYS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04895176
• Other study ID #: CORALYS
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2021
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Fabrizio D'Ascenzo, MD
• Phone: 0039 011 633 6023
• Email: fabrizio.dascenzo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Heart Failure
• Syndrome

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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