Status:
UNKNOWN
ARomatherapy for Cognitive Trajectory in Chinese After Percutaneous Coronary Intervention (ARCTIC-PCI)
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Peking University
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief 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 evalu...
Detailed Description
The ARCTIC-PCI trial has two objectives. The primary objective is to evaluate the efficacy of aromatherapy (70% menthol and 30% propanediol) in improving cognitive functions in Chinese post-PCI patien...
Eligibility Criteria
Inclusion
- Men and women aged between 50 and 75 years old.
- Patients with unstable angina, ST-segment elevation or non-ST elevation myocardial infarction who need stent implantation.
- Willing to come to hospital at 3- and 6- month after PCI.
- Signed informed consent.
Exclusion
- Emergency patients.
- Prior history of CABG(Coronary Artery Bypass Grafting),or other cardiac surgery.
- Prior history of heart failure.
- Prior history of atrial fibrillation.
- Prior history of allergic rhinitis, sinusitis, asthma and COPD.
- Deafness, mental illness including severe depression, and inability to communicate properly.
- Prior history of stroke.
- Prior history of brain tumor, traumatic brain injury, or other brain surgery.
- Relatives of researcher or management personnel.
- Family members been enrolled in the study.
- Known mild cognitive impairment or dementia.
- Mild cognitive impairment and dementia identified by cognitive function assessment before PCI.
- Prior history of smell disorder or decreased/loss of olfactory functions assessed by the Sniffin' Sticks test.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT04103086
Start Date
December 1 2019
End Date
June 1 2021
Last Update
September 30 2019
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