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L'essai clinique NCT06150989 (BLOOM) pour Maladies cardiovasculaires, Facteurs de risque de maladie cardiaque est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring (BLOOM)
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L'étude clinique NCT06150989 (BLOOM) est un essai observationnel pour Maladies cardiovasculaires, Facteurs de risque de maladie cardiaque. Son statut actuel est : en recrutement. L'étude a débuté le 4 mars 2024 et vise à recruter 80 participants. Dirigé par The University of Texas at Arlington, l'essai devrait être terminé d'ici le 1 mars 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 29 avril 2025.
Résumé succinct
This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.
Titre officiel
A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women
Conditions
Maladies cardiovasculairesFacteurs de risque de maladie cardiaquePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'essai
- BLOOM
- 2023-0344
Numéro NCT
Date de début (réel)
2024-03-04
Dernière mise à jour publiée
2025-04-29
Date de fin (estimée)
2026-03
Inscription (estimée)
80
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Observational Group Black women enrolled in this study will complete a series of lab-based assessments that evaluate their vascular health, followed by a 10-day free-living monitoring period with mobile and wearable devices. | Groupe d'observation All participants will go through a series of lab-based assessments to evaluate their vascular health. These assessments include: heart rhythm/rate, blood pressure, large blood vessel flow, central aortic blood pressure and pulse wave velocity, brain blood flow, carbon dioxide concentration, flow mediated dilation/blood vessel responsiveness, breathing rate, and cerebral vasomotor reactivity. In addition, venous blood sample will be taken to identify biomarkers that are associated with elevating blood pressure and decreasing blood flow.
The 10-day monitoring period includes a wrist-worn activity tracker and a blood pressure monitor bracelet; a smartphone app that will prompt surveys up to 6 times a day to assess behaviors, social/physical context, mood/stress, and experience of racial discrimination/microaggression. Participants will also collect saliva samples on three consecutive days during the 10-day monitoring period. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Macrovascular function | Macrovascular function will be assessed as brachial artery vasodilation following a period of suprasystolic cuff occlusion. Microvascular function will be assessed as the % change in blood velocity from baseline following cuff release. | Day 1 |
Arterial Stiffness | An appropriately sized blood pressure cuff will be placed on the upper arm and central (aortic) and peripheral (arm) blood pressure will be assessed using the non-invasive SphygmoCor Xcel device. This device provides measurement of augmentation index (in percentage), which is an indicator of arterial stiffness. | Day 1 |
Blood Flow Measurements (Large Blood Vessels) | A Doppler ultrasound probe will be used to measure blood flow in the upper arm, leg, and/or neck (e.g., brachial artery, femoral artery, and carotid artery, respectively). | Day 1 |
Blood Flow Measurements (Cerebral Blood Vessels) | Cerebral blood flow will be indexed from the velocity of blood flowing through the middle cerebral artery. This will be accomplished using transcranial Doppler ultrasound. | Day 1 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Physical activity | Daily physical activity level will be assessed via a wrist-worn accelerometer. | Day 2 to Day 11 |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
- born and identified as female;
- between 18-49 years old;
- self-identify as Black or African American;
- not currently pregnant;
- ownership of a smartphone with Internet access;
- able to speak and read English
- diagnosed hypertension, cardiovascular, respiratory, metabolic, and/or neurological disorders;
- functional limitations or health issues that preclude physical activity;
- currently taking medications for thyroid function or psychological conditions such as depression, anxiety, and mood disorders;
- current use of oral or inhalant corticosteroids for asthma;
- have regularly smoked within the last 2 years.
The University of Texas at ArlingtonAmerican Heart AssociationPartie responsable de l'essai
Yue Liao, Investigateur principal, Assistant Professor, The University of Texas at Arlington
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Texas
The University of Texas at Arlington, Arlington, Texas, 76010, United States
Physical Activity and Wearable Sensors Lab, Contact, 8172728524, [email protected]
Yue Liao, PhD, MPH, Investigateur principal
En recrutement