Intracerebral HemorrhageMNEMONICHNCT02567162
Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by The University of Texas Health Science Center at San Antonio.
Trial summary
The aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Aug 2016
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for ICH will be asked to provide their permission for the use of this information for retrospective research studies directed at ICH; such research to be conducted by the MNEMONICH investigators.
Who may be able to join
- Diagnosis of spontaneous intracerebral hemorrhage (ICH) met by clinical and imaging criteria
- Age 18 and above
- Able to consent
Who cannot join
- ICH due to trauma
- ICH due to vascular malformation or aneurysm
- ICH due to brain tumor
- ICH due to underlying infectious lesion (e.g., abscess)
About this study
Official title: Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage (MNEMONICH)
The aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.
Read the detailed description
MNEMONICH is a disease-specific registry of prospectively collected data obtained from the integration and harmonization of preexisting single-center data sets. It was formed to provide clinician-scientists around the world a comprehensive database to direct future studies toward better understanding of ICH. MNEMONICH will help examine global variability in the prevalence of ICH and identify research priorities.
New data for MNEMONICH will be prospectively collected on a wide range of features including demographics, medical history, dates and times of symptom onset, presentation symptoms, hemodynamic signs, initial and chronic medical therapy, diagnostic imaging, laboratory and genetic analyses, pathological data, and surgical and medical management. Future research will be based upon ad hoc analysis of this data.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Hemorrhagic stroke, Intraparenchymal hemorrhage, Cerebrovascular disease, Stroke
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke, Cerebrovascular Disorders, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
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 Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention, Hospital Interzonal de Agudos San Juan Bautista, Maastricht University Medical Center, University of Western Ontario, Canada, Northern Care Alliance NHS Foundation Trust, University of Manchester, University of Rostock, University of Medicine and Pharmacy Craiova, San Camillo de' Lellis General Hospital, Azienda USL Reggio Emilia - IRCCS, University of Central Florida, Manchester Metropolitan University
- Responsible party
- Principal investigator, Reza Behrouz, The University of Texas Health Science Center at San Antonio
- Investigators
- Mario Di Napoli, MD, Study director, Centre for Cardiovascular Medicine and Cerebrovascular Disease PreventionMahmoud R Azarpazhooh, MD, Principal investigator, Western University, CanadaReza Behrouz, DO, Principal investigator, The University of Texas Health Science Center at San AntonioLuca Masotti, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCSAdrian R Parry-Jones, MBChB, PhD, Principal investigator, University of Manchester and the Salford Royal NHS Foundation TrustAurel Popa-Wagner, MD, PhD, Principal investigator, University of RostockMark A Slevin, PhD, Principal investigator, Manchester Metropolitan UniversityCraig J Smith, MBChB, MD, Principal investigator, University of Manchester and the Salford Royal NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567162
- Sponsor's protocol ID
- HSC20150655H
- Acronym
- MNEMONICH
- Status last verified
- Dec 2016
- First submitted
- 30 Sep 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Behrouz R, Azarpazhooh MR, Godoy DA, Hoffmann MW, Masotti L, Parry-Jones AR, Popa-Wagner A, Schreuder FH, Slevin MA, Smith CJ, Di Napoli M; MNEMONICH Steering Committee. The Multi-National survey on Epidemiology, Morbidity, and Outcomes iN Intracerebral Haemorrhage (MNEMONICH). Int J Stroke. 2015 Dec;10(8):E86. doi: 10.1111/ijs.12629. No abstract available.
PubMed 26745705
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage (MNEMONICH)
- ClinicalTrials.gov ID
- NCT02567162
- Acronym / sponsor ID
- MNEMONICH / HSC20150655H
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Hemorrhagic stroke, Intraparenchymal hemorrhage, Cerebrovascular disease, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention, Hospital Interzonal de Agudos San Juan Bautista, Maastricht University Medical Center, University of Western Ontario, Canada, Northern Care Alliance NHS Foundation Trust, University of Manchester, University of Rostock, University of Medicine and Pharmacy Craiova, San Camillo de' Lellis General Hospital, Azienda USL Reggio Emilia - IRCCS, University of Central Florida, Manchester Metropolitan University
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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 aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.
Detailed description
MNEMONICH is a disease-specific registry of prospectively collected data obtained from the integration and harmonization of preexisting single-center data sets. It was formed to provide clinician-scientists around the world a comprehensive database to direct future studies toward better understanding of ICH. MNEMONICH will help examine global variability in the prevalence of ICH and identify research priorities.
New data for MNEMONICH will be prospectively collected on a wide range of features including demographics, medical history, dates and times of symptom onset, presentation symptoms, hemodynamic signs, initial and chronic medical therapy, diagnostic imaging, laboratory and genetic analyses, pathological data, and surgical and medical management. Future research will be based upon ad hoc analysis of this data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for ICH will be asked to provide their permission for the use of this information for retrospective research studies directed at ICH; such research to be conducted by the MNEMONICH investigators.
Key inclusion criteria (3 listed)
- Diagnosis of spontaneous intracerebral hemorrhage (ICH) met by clinical and imaging criteria
- Age 18 and above
- Able to consent
Key exclusion criteria (4 listed)
- ICH due to trauma
- ICH due to vascular malformation or aneurysm
- ICH due to brain tumor
- ICH due to underlying infectious lesion (e.g., abscess)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale score
Time frame: 90 days
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 9 Dec 2016.
- Background: PubMed 26745705Behrouz R, Azarpazhooh MR, Godoy DA, Hoffmann MW, Masotti L, Parry-Jones AR, Popa-Wagner A, Schreuder FH, Slevin MA, Smith CJ, Di Napoli M; MNEMONICH Steering Committee. The Multi-National survey on Epidemiology, Morbidity, and Outcomes iN Intracerebral Haemorrhage (MNEMONICH). Int J Stroke. 2015 Dec;10(8):E86. doi: 10.1111/ijs.12629. No abstract available.
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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.
Mario Di Napoli, MD study director
Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention
Mahmoud R Azarpazhooh, MD principal investigator
Western University, Canada
Reza Behrouz, DO principal investigator
The University of Texas Health Science Center at San Antonio
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by The University of Texas Health Science Center at San Antonio.
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 3 inclusion and 4 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Modified Rankin Scale score (time frame: 90 days). 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 NCT02567162, 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 9 Dec 2016.