Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04880317 |
| Other study ID # |
VALETUDO |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 7, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
December 2023 |
| Source |
IRCCS Policlinico S. Donato |
| Contact |
Francesco Sardanelli, MD |
| Phone |
0252774468 |
| Email |
francesco.sardanelli[@]unimi.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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).
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.
