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NCT02316314 · ClinicalTrials.gov registry record

Characterization of the Cardiac Phenotype of Friedreich's Ataxia (FRDA)

A clinical trial of Friedreich's Ataxia, sponsored by Weill Medical College of Cornell University.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT02316314: Recruiting study of Friedreich's Ataxia, sponsored by Weill Medical College of Cornell University.

NCT02316314 is a study of Friedreich's Ataxia that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 100 participants, above the 60-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02316314, a study of Friedreich's Ataxia, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study Summary

Friedreich's ataxia (FRDA) is an autosomal recessive disease characterized by loss of coordination and cardiomyopathy. It is the most common form of inherited ataxia with an incidence in 1/50,000 in the Caucasian population. FRDA is associated with progressive damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech problems, as well as diabetes and heart disease. The heart disease manifests as cardiomyopathy, and is responsible for approximately 60% of deaths from FRDA. This study is designed to characterize the cardiac manifestations of the disease using exercise, MRI, ECHO and serum parameters, in the context of the neurological disease. In addition, this study will demonstrate that corneal confocal microscopy (CCM) may also provide a biomarker for FRDA.

Primary Outcome

Average the levels of troponin for each subject

Conditions Studied

Interventions

  • PROCEDURE Cardiac magnetic resonance imaging (CMR)
  • PROCEDURE Exercise-stress test
  • PROCEDURE Echocardiogram (ECHO)
  • PROCEDURE Cardiac-related blood studies

Study Locations (1)

New York

  • Weill Cornell Medicine - New York

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2015-01-15
Est. Completion 2026-08

What NCT02316314 shows while recruiting

NCT02316314 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (67% higher).

The record links to 1 condition, with Friedreich's Ataxia appearing as the primary indexed condition, and to 4 interventions - of which Cardiac magnetic resonance imaging (CMR) is the first listed.

NCT02316314 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT02316314 about?

NCT02316314 is a clinical study titled "Characterization of the Cardiac Phenotype of Friedreich's Ataxia (FRDA)". Friedreich's ataxia (FRDA) is an autosomal recessive disease characterized by loss of coordination and cardiomyopathy. It is the most common form of inherited ataxia with an incidence in 1/50,000 in the Caucasian population. FRDA is associated with progressive damage to the nervous system, resulting...

What is the current status of trial NCT02316314?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2015-01-15. Estimated completion is 2026-08.

What conditions does trial NCT02316314 study?

This clinical trial studies the following conditions: Friedreich's Ataxia.

What interventions are being tested in trial NCT02316314?

The interventions under investigation include: Cardiac magnetic resonance imaging (CMR) (PROCEDURE), Exercise-stress test (PROCEDURE), Echocardiogram (ECHO) (PROCEDURE), Cardiac-related blood studies (PROCEDURE).

Who is sponsoring clinical trial NCT02316314?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02316314 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02316314, the US trial registry maintained by the National Library of Medicine. NCT02316314 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.