STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMI... | NCT05770336

Studies
STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

NCT05770336

Sponsor

IRCCS San Raffaele

Status

Completed

Last Update Posted

Mar 15, 2023Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Cardiac Complication
COVID-19 Pneumonia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2022Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Mar 12, 2023

First Submission Date that Met QC Criteria

Mar 12, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2023

Last Update Posted Date

Mar 15, 2023Actual

Name	Class
Rete cardiologica IRCCS	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Detailed Description

In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase.

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.

Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
Patient with previous hospitalization for Covid-19 infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.	The main purpose of this study is to identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage. The anatomical and functional substrates of cardiovascular manifestations will be analyzed by basic and advanced echocardiographic technologies	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
Adult patients between 18 and 90 years of age
Signature of informed consent

Exclusion Criteria:

Patient with poor echocardiographic acoustic window impairing the performance of the examination
Patients with atrial fibrillation
Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with previous hospitalization for Covid-19 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eustachio Agricola, MD	IRCCS San Raffaele	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCSS San Raffaele		Milan			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided