Clinical trial NCT02567162: Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage
Official title: Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage (MNEMONICH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral hemorrhage
Hemorrhagic stroke
Intraparenchymal hemorrhage
Cerebrovascular disease
Stroke
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention
name: Hospital Interzonal de Agudos San Juan Bautista
name: Maastricht University Medical Center
name: University of Western Ontario, Canada
name: Northern Care Alliance NHS Foundation Trust
name: University of Manchester
name: University of Rostock
name: University of Medicine and Pharmacy Craiova
name: San Camillo de' Lellis General Hospital
name: Azienda USL Reggio Emilia - IRCCS
name: University of Central Florida
name: Manchester Metropolitan University
First posted: 2015-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of spontaneous intracerebral hemorrhage (ICH) met by clinical and imaging criteria
* Age 18 and above
* Able to consent

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention
name: Mario Di Napoli, MD
role: STUDY_DIRECTOR
affiliation: Western University, Canada
name: Mahmoud R Azarpazhooh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Reza Behrouz, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Luca Masotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester and the Salford Royal NHS Foundation Trust
name: Adrian R Parry-Jones, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rostock
name: Aurel Popa-Wagner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Metropolitan University
name: Mark A Slevin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester and the Salford Royal NHS Foundation Trust
name: Craig J Smith, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Interzonal de Agudos San Juan Bautista
name: Daniel A Godoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Floris H Schreuder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Central Florida
name: Michael W Hoffmann, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.