Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study (HYSTERESIS)
To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities
Studieoversikt
Status
Detaljert beskrivelse
In this prospective study, consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
LVH will be defined by standard echocardiographic criteria, while obstructive CAD will be assessed by CCTA. Stress CMR will serve as the reference standard for inducible myocardial ischemia.
Exercise ECG parameters will include conventional ST-segment criteria as well as dynamic indices during exercise and recovery. Associations between ECG findings and imaging-defined phenotypes will be evaluated, and predictors of CAD-related ischemia will be identified.
Results The study will assess the diagnostic performance of exercise ECG across the four predefined groups. Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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PI
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Pisa, PI, Italia, 56124
- Rekruttering
- Azienda Ospedaliero-Universitaria Pisana
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Ta kontakt med:
- Mattia Alberti, MD, PhD candidate
- Telefonnummer: +39 3770805335
- E-post: mattia.alberti@phd.unipi.it
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Ta kontakt med:
- Morrone Doralisa, MD, PhD, Associate Professor
- E-post: doralisa.morrone@unipi.it
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Underetterforsker:
- Riccardo Canonaco, MD
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Underetterforsker:
- Simona Chiusolo, MD
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Underetterforsker:
- Simona Buralli, MD
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Underetterforsker:
- Stefano Taddei, MD, Full Professor
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Underetterforsker:
- Emanuele Neri, MD, Full Professor
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Underetterforsker:
- Giovanni Donato Aquaro, MD, PhD, Associate Professor
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Underetterforsker:
- Lorenzo Faggioni, MD, Associate Professor
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Underetterforsker:
- Doralisa Morrone, MD, PhD, Associate Professor
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Underetterforsker:
- Raffaele De Caterina, MD, PhD, Full Professor
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Underetterforsker:
- Pietro Lucii, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
Beskrivelse
Inclusion Criteria:
- Patients with CAD and LVH
Exclusion Criteria:
- Patients with RBBB
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
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LVH with obstructive CAD
LVH with obstructive CAD |
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LVH without obstructive CAD
LVH without obstructive CAD |
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No LVH with obstructive CAD
No LVH with obstructive CAD |
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No LVH without obstructive CAD
No LVH without obstructive CAD |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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diagnostic performance of exercise ECG across the four predefined groups.
Tidsramme: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
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Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia. |
From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HYSTERESIS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data (IPD) will be made available upon reasonable request following the completion of all planned analyses and subsequent publication of the resulting manuscripts
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