- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02101619
Assessment of Myocardial Tissue Damage in Aortic Stenosis
Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Moderate or severe aortic stenosis determined by echocardiography
- Adults > 65 years old
Exclusion Criteria:
- Ejection fraction < 50%
- Valvular diseases of more than or equal to moderate degree other than aortic stenosis
- Prior myocardial infarction or coronary artery disease needs revascularization
- Atrial fibrillation (chronic)
- Pacemaker/defibrillator implanted
- Previous valve replacement performed
- Cardiomyopathy(HCM, infiltrative cardiomyopathy, constriction)
- Renal dysfunction (estimated GFR < 30ml/min/1.73m² or end stage renal failure)
- Patients with contraindication for MRI
- Patients with poor echocardiographic images
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Moderate aortic stenosis.
|
Severe aortic stenosis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Presence of myocardial fibrotic change determined by MRI.
Tidsramme: 1 hour
|
1 hour
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hari Chaliki, MD, Mayo Clinic
- Ledende efterforsker: Minako Katayama, MD, Mayo Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13-004385
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