NCT05770336

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 9, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

March 12, 2023

Last Update Submit

March 12, 2023

Conditions

Cardiac ComplicationCOVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patient with previous hospitalization for Covid-19 infection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with previous hospitalization for Covid-19 infection

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCSS San Raffaele

Milan, Italy

Location

Study Officials

  • Eustachio Agricola, MD

    IRCCS San Raffaele

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 15, 2023

Study Start

March 9, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

IT(1)