Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— MNEMONICH  

Official title:

Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage (MNEMONICH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567162
• Other study ID #: HSC20150655H
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: December 8, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeCanada: Ethics Review CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeUnited Kingdom: Research Ethics CommitteeUnited States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor

Collaborator

The University of Texas Health Science Center at San Antonio

Arcispedale Santa Maria Nuova-IRCCS, Centre for Cardiovascular Medicine and Cerebrovascular Disease Prevention, Hospital Interzonal de Agudos San Juan Bautista, Maastricht University Medical Center, Manchester Metropolitan University, Salford Royal NHS Foundation Trust, San Camillo de' Lellis General Hospital, University of Central Florida, University of Manchester, University of Medicine and Pharmacy Craiova, University of Rostock, University of Western Ontario, Canada

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale score		90 days	No