Clinical Trials Logo

Clinical Trial Summary

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired clonal hematological disorder, which can cause arterial or venous thrombosis. The frequency of PNH in young patients (< 50 years old) with embolic stroke (ESUS), transient ischemic attack (ETUS) or superior sagittal sinus cerebral venous thrombosis (SSS-CVTUS) of undetermined source, is currently unknown. This study proposes to recruit ESUS, ETUS, SSS-CVTUS patients to determine the frequency of PNH diagnosis confirmed by flow cytometry in these patient populations.

Clinical Trial Description

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired clonal hematological disorder leading to red blood cells hemolysis and thrombosis. PNH has been reported to be the cause of cerebral venous thrombosis and embolic ischemic strokes and is sometimes diagnosed after the ischemic event. In young patients with embolic ischemic stroke of undetermined source (ESUS), thrombophilia is usually investigated. However, access to PNH testing is limited. PNH is rarely investigated in stroke patients and its contribution to the pathophysiology of ESUS is unknown. The investigators hypothesize that this condition is underdiagnosed, resulting in potential preventive opportunities being lost, since PNH can be successfully treated.

This observational study aims to determine the frequency of PNH among young (≤50 years old) patients with recent ESUS or embolic transient ischemic attacks (TIA) of undetermined source (ETUS) and patients with SSS-CVT of undetermined source (SSS-CVTUS).

Patients with ESUS or ETUS will be first screened for: (a) evidence of hemolysis based on their plasma lactate dehydrogenase (LDH) levels, (b) unexplained anemia based on their hemoglobin (Hb) levels, and (c) unexplained cytopenia (e.g., neutropenia and thrombocytopenia). Flow cytometry analysis for PNH will be performed with blood samples collected from subjects with abnormal level of plasma LDH (1.5X ULN) or unexplained anemia or cytopenia.

Patients with SSS-CVTUS will undergo flow cytometry without prior screening.

In addition, plasma and DNA samples will be collected in an optional sub-study for future analysis of DNA mutations related to specific PNH phenotypes in patients with stroke. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03329365
Study type Observational
Source Lawson Health Research Institute
Contact Justina Diaz Legaspe
Phone 519-685-8500
Status Recruiting
Start date November 1, 2018
Completion date January 2020

See also
  Status Clinical Trial Phase
Recruiting NCT00859885 - International PFO Consortium N/A
Not yet recruiting NCT03605355 - Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT02141932 - Pocket-size Cardiovascular Ultrasound in Stroke N/A
Recruiting NCT01954329 - Markers in the Diagnosis of TIA N/A
Active, not recruiting NCT02011256 - Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack N/A
Active, not recruiting NCT01918891 - Center for Stroke Disparities Solution - Community Transitions Intervention N/A
Recruiting NCT01526824 - Lovaza's Effect on Clopidogrel in a Neuro Population Phase 0
Completed NCT01020851 - The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial N/A
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Completed NCT00211731 - Preventing Recurrent Stroke in Minority Populations N/A
Not yet recruiting NCT03648957 - Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack N/A
Completed NCT00885456 - Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT Phase 2
Active, not recruiting NCT02642744 - Improving Coordination and Transitions of Care in Stroke Patients N/A
Terminated NCT00816166 - VISSIT Intracranial Stent Study for Ischemic Therapy Phase 2/Phase 3
Recruiting NCT03724110 - Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals
Recruiting NCT03710902 - Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke N/A
Recruiting NCT03417063 - Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression N/A
Recruiting NCT01951612 - Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors N/A
Completed NCT00390962 - The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment) N/A