Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA (NOCAWT)
Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries). We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC). The upper age limit was established to limit the influence of vascular senescence on the results.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Eduardo Tibirica, MD, PhD
- Numero di telefono: +55-21-99914-6075
- Email: etibi@uol.com.br
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients from a terciary cardiology hospital.
Descrizione
Inclusion Criteria:
- Age 18-65 years
- Anginal chest pain
Exclusion Criteria:
- Malignant neoplasms
- Autoimmune diseases
- Acute systemic diseases
- Pregnancy or lactation
- Iodine allergy
- CAD on invasive coronary angiography or coronary computed tomography angiography (CCTA)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
ANOCA
Symptomatic Group (ANOCA): n = 40 patients with stable angina and non-obstructive coronary arteries. |
Investigation of Systemic Endothelial Microvascular Function
Altri nomi:
|
|
CONTROL
Control Group: n = 20 age-matched women without chest pain and without CAD. |
Investigation of Systemic Endothelial Microvascular Function
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of endothelium-dependent skin microvascular reactivity.
Lasso di tempo: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance. |
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of endothelium-independent skin microvascular reactivity.
Lasso di tempo: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by endothelium-independent agent (sodium nitroprusside). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance. |
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
|
Evaluation of endothelium-dependent skin microvascular reactivity.
Lasso di tempo: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by postocclusive reactive hyperemia. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance. |
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
|
Evaluation of sublingual microcirculation.
Lasso di tempo: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Sublingual microcirculatory density and perfusion will be assessed using a handheld camera based on incident dark-field (IDF) imaging. |
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NOCoronaryArtery Women Testing
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .