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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02567162
Other study ID # HSC20150655H
Secondary ID
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


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
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