Aging, PrematureNCT03487302
White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
An observational study of Aging, Premature and Congenital Heart Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Premature, Congenital Heart Disease, White Matter Hyperintensities
- What is being tested?
- Brain MRI and Neuropsychological test battery
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2017to 31 Dec 2021
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not; * for the control group, being an healthy subject.
Who may be able to join
- for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
- for the control group, being an healthy subject.
Who cannot join
- any contraindication to magnetic resonance imaging;
- any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:
- inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;
- ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;
- genetic diseases (whether mendelian or mitochondrial) of the CNS;
- cerebral amyloid angiopathy;
Show all 12Show fewer
- CADASIL;
- cerebral arteriovenous malformations;
- primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;
- patent oval foramen;
- being pregnant;
- migraine with aura (Bashir, Lipton, Ashina, \& Ashina, 2013).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.
Read the detailed description
White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)
- Being tested
- Brain MRI, Neuropsychological test battery
- Medical subject headings
- Aging, Premature, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans
Neuropsychological test batteryOther
- Mini Mental State Examination (MMSE), Measso et al. (1993);
- Frontal Assessment Battery (FAB), Appollonio et al. (2005);
- Symbol Digit Test, Amodio et al. (2002);
- Digit Cancellation Test, Della Sala et al. (1992);
- Trial Making Test (TMT A-B), Giovagnoli et al. (1996);
- Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010);
- Digit Span, Orsini et al (1987);
- Corsi block-tapping test, Orsini et al. (1987);
- Babcock story recall test, Carlesimo et al. (2002);
- Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010);
- Semantic verbal fluency, Novelli (1986);
- Imitating gestures, De Renzi et al. (1980);
- Coloured Progressive Matrices (CPM47), Measso et al. (1993).
| Study group | Role | What they receive |
|---|---|---|
| cCHD | Not described Receives: Other: Brain MRI; Other: Neuropsychological test battery | |
| CONTROLS | Not described Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter hyperintensities volume expressed in mm^3
Semi-automated quantification performed through ITK-SNAP
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start17 Oct 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging, PrematureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sardanelli, IRCCS Policlinico S. Donato
- Investigators
- Francesco Sardanelli, MD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487302
- Sponsor's protocol ID
- LEUCO
- Status last verified
- Sep 2022
- First submitted
- 20 Mar 2018
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yushkevich PA, Piven J, Hazlett HC, Smith RG, Ho S, Gee JC, Gerig G. User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability. Neuroimage. 2006 Jul 1;31(3):1116-28. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20.
PubMed 16545965
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT03487302
- Acronym / sponsor ID
- LEUCO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Apr 2018 (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 study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.
Detailed description
White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cCHD | – | Other: Brain MRI, Other: Neuropsychological test battery |
| CONTROLS | – | Other: Brain MRI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not; * for the control group, being an healthy subject.
Key inclusion criteria (2 listed)
- for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
- for the control group, being an healthy subject.
Key exclusion criteria (12 listed)
- any contraindication to magnetic resonance imaging;
- any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:
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 |
|---|---|---|
| Brain MRIAcquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans | Other | CONTROLS, cCHD |
| Neuropsychological test battery1. Mini Mental State Examination (MMSE), Measso et al. (1993); 2. Frontal Assessment Battery (FAB), Appollonio et al. (2005); 3. Symbol Digit Test, Amodio et al. (2002); 4. Digit Cancellation Test, Della Sala et al. (1992); 5. Trial Making Test (TMT A-B), Giovagnoli et al. (1996); 6. Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010); 7. Digit Span, Orsini et al (1987); 8. Corsi block-tapping test, Orsini et al. (1987); 9. Babcock story recall test, Carlesimo et al. (2002); 10. Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010); 11. Semantic verbal fluency, Novelli (1986); 12. Imitating gestures, De Renzi et al. (1980); 13. Coloured Progressive Matrices (CPM47), Measso et al. (1993). | Other | cCHD |
Primary outcome
White matter hyperintensities volume expressed in mm^3
Time frame: 3 years
Semi-automated quantification performed through ITK-SNAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 16545965Yushkevich PA, Piven J, Hazlett HC, Smith RG, Ho S, Gee JC, Gerig G. User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability. Neuroimage. 2006 Jul 1;31(3):1116-28. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20.
- Individual participant dataSharing planned: No
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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.
Francesco Sardanelli, MD principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, Premature and Congenital Heart Disease, 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 12 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: finished, as of the sponsor's last update on 13 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
White matter hyperintensities volume expressed in mm^3 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487302, which also lists 1 linked publication.
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 13 Sep 2022.