drugset / Trial / NCT04103086

ARomatherapy for Cognitive Trajectory in Chinese After Percutaneous Coronary Intervention (ARCTIC-PCI)

NCT04103086 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The ARCTIC-PCI (Aromatherapy for Cognitive Trajectory in Chinese after Percutaneous Coronary Intervention) trial is a randomized, double-blind, 2-arm, parallel group, placebo-controlled study to evaluated the effects of aromatherapy in improving cognitive function in post-percutaneous coronary intervention (PCI) patients. The study will recruit 660 patients who undergo a PCI at the Department of Cardiology in Beijing Anzhen Hospital. Baseline information will be collected prior to PCI, all eligible participants undergoing PCI will be randomly assigned in a 1:1 ratio before hospital discharge to receive aromatherapy (70% menthol and 30% propanediol) or placebo (10% menthol and 90% propanediol). The treatment will last for 6 months in both groups. Cognitive function measurement will be conducted by blinded assessors at baseline (1-3 days before PCI) and at 3- and 6- month after PCI. The primary outcome will be the change in overall cognitive function (MOCA score) from baseline to 6-month after PCI.

Timeline

Start
2019-12
Primary completion
2020-12
Completion
2021-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Aromatherapy Unknown — Inhaled

Indications

No indication recorded.