NCT04895176

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

29 days

First QC Date

May 17, 2021

Last Update Submit

May 17, 2021

Conditions

Acute Coronary SyndromeHeart Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • The relation between the type of ACS and incidence of HF

    12 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Related Publications (2)

  • 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.

    PMID: 37734293DERIVED

  • 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.

    PMID: 37489724DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Fabrizio D'Ascenzo, MD

    AOU Città della salute e della Scienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrizio D'Ascenzo, MD

CONTACT

0039 011 633 6023fabrizio.dascenzo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Locations

IT(1)