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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101619
The ClinicalTrials.gov registry entry for NCT02101619 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02101619 reports 0 study locations.
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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