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

NCT04103086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2019-09-30

No results posted yet for this study

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.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DRUG

Aromatherapy

Free aromatherapy (70% menthol and 30% propanediol) will be provided for 6 months. All participants will receive the standard inhalation method training before hospital discharge. The aromatherapy will be given twice daily, one treatment in the morning and one in the evening. At each treatment, 4 deep steady inhalations will be performed, and 10 seconds per inhalation is optimal.

DRUG

Placebo

Free placebo (10% menthol and 90% propanediol) will be provided for 6 months. The specific method is the same as aromatherapy

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-12-31
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103086 on ClinicalTrials.gov