Amyloid AngiopathyNCT03262246
Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid
An observational study of Amyloid Angiopathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Amyloid Angiopathy
- What is being tested?
- medical report consultation
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2016to 31 Dec 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators select medical report of hospitalized patient between 2011/01/01 and 2015/12/31 in CAEN hospital and Paris St Joseph hospital ; these had an MRI for cerebral haemorrhage.
Who may be able to join
- age>55
- hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral amyloid angiopathy.
Who cannot join
- Insufficient MRI images quality without FLAI sequence, T2 GRE
- disease with same radiologic and clinical signs that cerebral amyloid angiopathy.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.
Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.
Read more
However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.
Besides, the risk factors of severity of the AAC are little studied.
- Conditions
- Amyloid Angiopathy
- Being tested
- medical report consultation
- Medical subject headings
- Amyloid angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical report consultationOther
investigators consult medical report concerning patient identified for cerebral amyloid angiopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start2 Jun 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid AngiopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HODEL Jérome, Professor, Principal investigator, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262246
- Sponsor's protocol ID
- ISAAC
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid
- ClinicalTrials.gov ID
- NCT03262246
- Acronym / sponsor ID
- ISAAC
- Conditions
- Amyloid Angiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Aug 2017 (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 cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.
Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.
However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.
Besides, the risk factors of severity of the AAC are little studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators select medical report of hospitalized patient between 2011/01/01 and 2015/12/31 in CAEN hospital and Paris St Joseph hospital ; these had an MRI for cerebral haemorrhage.
Key inclusion criteria (2 listed)
- age>55
- hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral amyloid angiopathy.
Key exclusion criteria (2 listed)
- Insufficient MRI images quality without FLAI sequence, T2 GRE
- disease with same radiologic and clinical signs that cerebral amyloid angiopathy.
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 |
|---|---|---|
| medical report consultationinvestigators consult medical report concerning patient identified for cerebral amyloid angiopathy | Other | – |
Primary outcome
number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients
Time frame: 1day
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 4 Feb 2019.
Related trials for Amyloid Angiopathy
Active, not recruitingPhase 2
A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy
RecruitingPhase 3
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy
RecruitingObservational study
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy
Recruiting
Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)
Stroke, Moyamoya Disease
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of NPI-001 in Patients With Hereditary Cystatin C Amyloid Angiopathy (HCCAA)
Hereditary Cystatin C Amyloid Angiopathy (HCCAA), Hemorrhage Brain
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.
HODEL Jérome, Professor principal investigator
GHPSJ
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 Amyloid Angiopathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 2 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 4 Feb 2019. 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 France. 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?
number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients (time frame: 1day). 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 4 Feb 2019.