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NCT02101619 · ClinicalTrials.gov registry record

Assessment of Myocardial Tissue Damage in Aortic Stenosis

A clinical trial, sponsored by Mayo Clinic.

Completed
Registry status
59
Enrollment target

NCT02101619: Completed study, sponsored by Mayo Clinic.

NCT02101619 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02101619 has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
59 participants
Enrollment target

Study Summary

Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention. The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2013-08
Est. Completion 2016-06
Mayo Clinic

2,844 total trials

What the finished NCT02101619 record still lists

NCT02101619 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02101619 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02101619 about?

NCT02101619 is a clinical study titled "Assessment of Myocardial Tissue Damage in Aortic Stenosis". Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical interventio...

What is the current status of trial NCT02101619?

This trial is currently completed. The enrollment target is 59 participants. The study started on 2013-08. Estimated completion is 2016-06.

Who is sponsoring clinical trial NCT02101619?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02101619, the US trial registry maintained by the National Library of Medicine. NCT02101619 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.