NCT04880317

Brief Summary

The main aim is to validate non-gated 5-min computed tomography myocardial relative enhancement (CT-MRE), which can be readily estimated via contrast-enhanced non-gated chest CT, as a tool for estimating myocardial extracellular volume (ECV) using cardiac magnetic resonance (CMR)-derived ECV as a reference standard in a consecutive series of patients scheduled for cardiac CT. A secondary explorative aim is to evaluate the presence and extent of possible myocardial alterations in those patients enrolled in the VALETUDO study who have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 2, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

May 2, 2021

Last Update Submit

July 3, 2025

Conditions

Cardiac DiseaseCovid19CardiotoxicityExtracellular Space Alteration

Keywords

Tomography X-Ray ComputedMagnetic Resonance ImagingCardiotoxicityExtracellular Space

Outcome Measures

Primary Outcomes (1)

  • Validation of CT-MRE as a surrogate of CMR-ECV

    CT-MRE will be calculated as (1-hematocrit) multiplied by the ratio of the differences in image density between post- and pre-contrast images in the myocardium and blood pool. Thus, CT-MRE will be represented by a percentage value. It will be calculated by placing regions of interest on the appropriate CT images.

    3 months

Secondary Outcomes (2)

  • Assessment of correlations between CMR-derived myocardial strain, CMR-ECV and CT-MRE

    3 months

  • Role of ECV as a biomarker of chronic cardiac damage following SARS-CoV-2 infection

    3 months

Study Arms (1)

Single arm

EXPERIMENTAL
Diagnostic Test: Cardiac Magnetic ResonanceDiagnostic Test: Additional CT acquisitionDiagnostic Test: Blood tests

Interventions

Cardiac Magnetic ResonanceDIAGNOSTIC_TEST

All enrolled patients will undergo a contrast-enhanced CMR examination for the assessment of extracellular volume

Single arm
Additional CT acquisitionDIAGNOSTIC_TEST

All enrolled patients will undergo an additional CT scan at 5 minutes post-contrast injection to evaluate myocardial relative enhancement

Single arm
Blood testsDIAGNOSTIC_TEST

Patients will undergo blood tests to review hematocrit, Sars-CoV-2 antibody status and cardiac fibrosis biomarkers

Single arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for contrast-enhanced cardiac CT
  • Age 18 to 80 years

You may not qualify if:

  • Absolute contraindications to CMR
  • Implantable cardioverter defibrillators and ferromagnetic thoracic devices which may cause artifacts at magnetic resonance imaging
  • Previous allergic reactions to gadolinium-based contrast agents
  • Pregnancy
  • Severe obesity
  • Severe claustrophobia
  • Too low image quality to perform post-processing analyses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

MeSH Terms

Conditions

Heart DiseasesCOVID-19Cardiotoxicity

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Radiology

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 10, 2021

Study Start

May 7, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

IT(1)