Abstract TP39: A Phase 2a randomized controlled trial of once-daily versus twice-daily remote ischemic conditioning in vascular cognitive impairment (TRIC-VCI)
Notice bibliographique
Résumé
Background: Cerebral small vessel disease (CSVD) is a leading cause of vascular cognitive impairment (VCI). Remote ischemic conditioning (RIC) is a promising strategy to prevent CSVD progression, but it is unclear what doses of daily RIC are tolerable or adherable for older patients with CSVD-associated VCI. Methods: TRIC-VCI (ClinicalTrials.gov NCT04109963) was a prospective, open-label randomized-controlled trial with blinded endpoint assessment. Participants completing a 14-day run-in were randomized to once- or twice-daily RIC for 30 consecutive days. RIC consisted of 4 cycles of blood-pressure cuff inflation to 200mmHg around an arm for 5-minutes followed by 5-minutes deflation using an automated device. Criteria included age 60-85, evidence of CSVD on CT/MRI, Montreal Cognitive Assessment score 13-24, and preserved basic activities of daily living. Outcomes were assessed at 30- and 90-days. The primary outcome for which the trial was powered was adherence (completing ≥80% of sessions). Secondary outcomes included percentage of sessions completed and pain/discomfort scores from patient diaries. Exploratory outcomes included changes in white-matter hyperintensity (WMH) volume and cognitive tests. We explored trial experiences in a focus group with 5 patients and 4 care-partners. Results: Among 23 patients entering the run-in, 22 completed it and were randomized. 21/22(95.5%) finished the 30-day treatment period. 7/11(63.6%) in the once-daily RIC group completed ≥80% of sessions vs 10/11(90.9%) in the twice-daily group; median session completion was 93%(IQR:73-98%) vs 98%(IQR:93-98%) respectively. Pain/discomfort ratings were numerically higher in the twice-daily group (median rating/10: 4.2, IQR 1.0-5.0 vs once-daily:1.6, IQR 1.0-3.4, p=0.60). None of the patients developed tissue/neurovascular injury or deep vein thrombosis. Cognitive tests generally did not change significantly or differ between groups; WMH volumes were stable (change at 90-days vs randomization: -0.21 mL, 95%CI -0.54-0.13). Focus group participants opined the device was easy to use, desired greater portability, generally favoured once-daily RIC, and were open to longer treatment courses in future trials. Conclusion: RIC was safe and tolerated by patients with CSVD-associated VCI. Patients adhered well to both once- and twice-daily RIC, with no significant differences in outcomes between both groups. We will incorporate participant feedback into device design and future efficacy trials.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».