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- Essai clinique NCT03334565
Reducing PM-associated CV Health Effects for Seniors
Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.
We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.
Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.
The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 50 to 85 years old
- non-smoking healthy adults
Exclusion Criteria:
- smoke or anyone in your residence smokes.
- had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
- have renal disease requiring dialysis.
- have had medication changes in the past 6 weeks.
- use supplementary oxygen.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur factice: Sham
Participants were exposed to unfiltered ambient air (sham) filtered air using air filtration systems in the bedroom and main living space of each residence.
|
Subjects were exposed to unfiltered air.
|
|
Comparateur actif: Low efficiency
Participants were exposed to low-efficiency (LE) "HEPA-type" filtered air using air filtration systems in the bedroom and main living space of each residence.
|
Subjects were exposed to low-efficiency filtered air.
|
|
Comparateur actif: High efficiency
Participants were exposed to high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.
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Subjects were exposed to high-efficiency filtered air.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
brachial blood pressure
Délai: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Brachial blood pressure was measured using a BPTru device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
noninvasive aortic hemodynamics
Délai: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Aortic hemodynamics was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
Pulse wave velocity
Délai: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Pulse wave velocity was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
heart rate variability
Délai: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Heart rate variability was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
microvasculature tone
Délai: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Retinal photography was used to measure retinal arteriole diameters.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Collaborateurs et enquêteurs
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Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01NR014484 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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