- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07847463
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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PI
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Pisa, PI, Italien, 56124
- Rekrytering
- Azienda Ospedaliero-Universitaria Pisana
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Kontakt:
- Mattia Alberti, MD, PhD candidate
- Telefonnummer: +39 3770805335
- E-post: mattia.alberti@phd.unipi.it
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Kontakt:
- Morrone Doralisa, MD, PhD, Associate Professor
- E-post: doralisa.morrone@unipi.it
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Underutredare:
- Riccardo Canonaco, MD
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Underutredare:
- Simona Chiusolo, MD
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Underutredare:
- Simona Buralli, MD
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Underutredare:
- Stefano Taddei, MD, Full Professor
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Underutredare:
- Emanuele Neri, MD, Full Professor
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Underutredare:
- Giovanni Donato Aquaro, MD, PhD, Associate Professor
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Underutredare:
- Lorenzo Faggioni, MD, Associate Professor
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Underutredare:
- Doralisa Morrone, MD, PhD, Associate Professor
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Underutredare:
- Raffaele De Caterina, MD, PhD, Full Professor
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Underutredare:
- Pietro Lucii, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
Inclusion Criteria:
- Patients with CAD and LVH
Exclusion Criteria:
- Patients with RBBB
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
LVH with obstructive CAD
LVH with obstructive CAD |
|
LVH without obstructive CAD
LVH without obstructive CAD |
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No LVH with obstructive CAD
No LVH with obstructive CAD |
|
No LVH without obstructive CAD
No LVH without obstructive CAD |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
diagnostic performance of exercise ECG across the four predefined groups.
Tidsram: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
|
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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HYSTERESIS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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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