Cardiac DiseaseNCT04880317
Validation of Quantitative Myocardial Tissue Characterization Through Non-gated CT
A study testing Cardiac Magnetic Resonance, Additional CT acquisition and Blood tests in people with Cardiac Disease and Covid19, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Covid19, Cardiotoxicity
- What is being tested?
- Cardiac Magnetic Resonance, Additional CT acquisition and Blood tests
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred for contrast-enhanced cardiac CT
- Age 18 to 80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Quantitative Myocardial Tissue Characterization Through Contrast-enhanced Non-gated CT Versus CMR: The VALETUDO-CT Study
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).
Read the detailed description
Patients scheduled to undergo contrast-enhanced cardiac CT and meeting inclusion criteria will be proposed enrolment in the study, and as such they will be informed on the study aims and design and will be invited to sign a specific informed consent. All potential enrollees will be invited to undergo an additional CT acquisition as part of their cardiac CT examination, to estimate CT-MRE, blood tests, and a contrast-enhanced CMR scan. All those meeting exclusion criteria (contraindications to CMR, previous allergic reactions to gadolinium-based contrast agents, pregnancy, severe obesity, claustrophobia) will be consequently excluded from the study. Patients with a previous diagnosis of COVID-19 will not be excluded if they are declared negative according to the procedure provided for by the regulations in force.
For all those eventually included to participate in the study, the CT examination will include the addition of a non-gated 5-min delayed acquisition, allowing the assessment of CT-MRE. All enrolled patients will then undergo blood tests including the assessment of haematocrit for the calculation of ECV and CT-MRE, and serological testing for COVID-19 antibodies. An additional blood sample (for a total of 30 ml of venous blood) will be tested for myocardial fibrosis biomarkers (Troponin, Osteopontin, ST, and Osteocalcin), and the remaining samples will be long-term bio-banked pending patients' approval.
All enrolled patients will then undergo a CMR examination within 10 days of the cardiac CT scan, including the intravenous administration of a macrocyclic gadolinium-based contrast agent, including cine sequences for myocardial function and strain assessment, and native- and contrast-enhanced T1 mapping for myocardial ECV calculation.
Myocardial CT-MRE and CMR-derived ECV calculation will be conducted according to methods previously described by the two centres. All CT and CMR exams will be anonymized, and segmentation for such purposes will be performed by readers with extensive experience in cardiovascular CT and CMR. Additionally, myocardial strain will be calculated from CMR cine sequences, through dedicated software.
Taking into consideration the known correlation between CT- and CMR-derived ECV and given the correlation between CT-MRE and CT-derived ECV noted in a previous study from our group, we would expect the coefficient of the correlation between CT-MRE and CMR-derived ECV not to be lower than 0.3. On these grounds, aiming for an α error of 0.05 and a statistical power (1 - β) of 0.90, we would require a sample size of 113 patients for our principal aim. Considering a potential maximum dropout rate around 40% (mostly due to the refusal to undergo CMR on a subsequent date from cardiac CT), we aim to enrol 188 patients for our study.
Normality will be evaluated using Shapiro-Wilk test. In case of normal distribution, t-tests will be used to assess differences between groups, and Pearson's r will be used for correlations. In case of non-normal distributions, Mann-Whitney and Wilcoxon tests will be used to assess differences, and Spearman's ρ for correlations. P-values ≤0.05 will be considered as indicative of statistical significance.
- Being tested
- Cardiac Magnetic Resonance, Additional CT acquisition, Blood tests
- Keywords
- Tomography X-Ray Computed, Magnetic Resonance Imaging, Cardiotoxicity, Extracellular Space
- Medical subject headings
- Heart Diseases, COVID-19, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic ResonanceDiagnostic test
All enrolled patients will undergo a contrast-enhanced CMR examination for the assessment of extracellular volume
Additional CT acquisitionDiagnostic test
All enrolled patients will undergo an additional CT scan at 5 minutes post-contrast injection to evaluate myocardial relative enhancement
Blood testsDiagnostic test
Patients will undergo blood tests to review hematocrit, Sars-CoV-2 antibody status and cardiac fibrosis biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance; Diagnostic Test: Additional CT acquisition; Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Assessment of correlations between CMR-derived myocardial strain, CMR-ECV and CT-MRE
Myocardial strain will be calculated via feature tracking algorithms, segmenting the endocardium and epicardium on cine images. As strain represents the ratio between the difference in displacement of the myocardial wall and its original position, it will be represented by a percentage. Strain will be measured in its longitudinal, radial and circumferential components.
Measured: 3 months
Role of ECV as a biomarker of chronic cardiac damage following SARS-CoV-2 infection
ECV will be calculated as the product between (1-hematocrit) and the ratio of the differences in image intensity between pre- and post-contrast T1 maps in the myocardium and blood pool. Data for this calculation will be derived by placing regions of interest in the appropriate MRI T1 maps. ECV is thus represented by a percentual value
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 May 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Why it stopped: PI ceased activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Principal investigator, Francesco Sardanelli, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880317
- Sponsor's protocol ID
- VALETUDO
- Status last verified
- Jul 2025
- First submitted
- 2 May 2021
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Quantitative Myocardial Tissue Characterization Through Contrast-enhanced Non-gated CT Versus CMR: The VALETUDO-CT Study
- ClinicalTrials.gov ID
- NCT04880317
- Acronym / sponsor ID
- VALETUDO
- Keywords
- Tomography X-Ray Computed, Magnetic Resonance Imaging, Cardiotoxicity, Extracellular Space
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI ceased activity
- Enrolment
- 33 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients scheduled to undergo contrast-enhanced cardiac CT and meeting inclusion criteria will be proposed enrolment in the study, and as such they will be informed on the study aims and design and will be invited to sign a specific informed consent. All potential enrollees will be invited to undergo an additional CT acquisition as part of their cardiac CT examination, to estimate CT-MRE, blood tests, and a contrast-enhanced CMR scan. All those meeting exclusion criteria (contraindications to CMR, previous allergic reactions to gadolinium-based contrast agents, pregnancy, severe obesity, claustrophobia) will be consequently excluded from the study. Patients with a previous diagnosis of COVID-19 will not be excluded if they are declared negative according to the procedure provided for by the regulations in force.
For all those eventually included to participate in the study, the CT examination will include the addition of a non-gated 5-min delayed acquisition, allowing the assessment of CT-MRE. All enrolled patients will then undergo blood tests including the assessment of haematocrit for the calculation of ECV and CT-MRE, and serological testing for COVID-19 antibodies. An additional blood sample (for a total of 30 ml of venous blood) will be tested for myocardial fibrosis biomarkers (Troponin, Osteopontin, ST, and Osteocalcin), and the remaining samples will be long-term bio-banked pending patients' approval.
All enrolled patients will then undergo a CMR examination within 10 days of the cardiac CT scan, including the intravenous administration of a macrocyclic gadolinium-based contrast agent, including cine sequences for myocardial function and strain assessment, and native- and contrast-enhanced T1 mapping for myocardial ECV calculation.
Myocardial CT-MRE and CMR-derived ECV calculation will be conducted according to methods previously described by the two centres. All CT and CMR exams will be anonymized, and segmentation for such purposes will be performed by readers with extensive experience in cardiovascular CT and CMR. Additionally, myocardial strain will be calculated from CMR cine sequences, through dedicated software.
Taking into consideration the known correlation between CT- and CMR-derived ECV and given the correlation between CT-MRE and CT-derived ECV noted in a previous study from our group, we would expect the coefficient of the correlation between CT-MRE and CMR-derived ECV not to be lower than 0.3. On these grounds, aiming for an α error of 0.05 and a statistical power (1 - β) of 0.90, we would require a sample size of 113 patients for our principal aim. Considering a potential maximum dropout rate around 40% (mostly due to the refusal to undergo CMR on a subsequent date from cardiac CT), we aim to enrol 188 patients for our study.
Normality will be evaluated using Shapiro-Wilk test. In case of normal distribution, t-tests will be used to assess differences between groups, and Pearson's r will be used for correlations. In case of non-normal distributions, Mann-Whitney and Wilcoxon tests will be used to assess differences, and Spearman's ρ for correlations. P-values ≤0.05 will be considered as indicative of statistical significance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Diagnostic Test: Cardiac Magnetic Resonance, Diagnostic Test: Additional CT acquisition, Diagnostic Test: Blood tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for contrast-enhanced cardiac CT
- Age 18 to 80 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic ResonanceAll enrolled patients will undergo a contrast-enhanced CMR examination for the assessment of extracellular volume | Diagnostic test | Single arm |
| Additional CT acquisitionAll enrolled patients will undergo an additional CT scan at 5 minutes post-contrast injection to evaluate myocardial relative enhancement | Diagnostic test | Single arm |
| Blood testsPatients will undergo blood tests to review hematocrit, Sars-CoV-2 antibody status and cardiac fibrosis biomarkers | Diagnostic test | Single arm |
Primary outcome
Validation of CT-MRE as a surrogate of CMR-ECV
Time frame: 3 months
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.
2 secondary outcomes
Assessment of correlations between CMR-derived myocardial strain, CMR-ECV and CT-MRE
Time frame: 3 months
Role of ECV as a biomarker of chronic cardiac damage following SARS-CoV-2 infection
Time frame: 3 months
Results and safety
The study was stopped early (reason given: PI ceased activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance, Additional CT acquisition and Blood tests in people with Cardiac Disease and Covid19, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI ceased activity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of CT-MRE as a surrogate of CMR-ECV (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.