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

NCT04103086 | Unknown DMC

• 1 other identifier: BeijingAnzhen-2019-06-PCI
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Percutaneous Coronary Intervention; Aromatherapy; Cognitive function; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (7)

• Changes in the overall cognitive function at 6 months after PCI

  Changes in the overall cognitive function in the Aromatherapy group versus changes in the overall cognitive function in the placebo group. MOCA (MOCA-Montreal Cognitive Assessment) will be used to measure the overall cognitive function.

  before and after 6-month intervention

• Changes in the overall cognitive function at 3 months after PCI

  Changes in the overall cognitive function in the Aromatherapy group versus changes in the overall cognitive function in the placebo group. MOCA (MOCA-Montreal Cognitive Assessment) will be used to measure the overall cognitive function.

  before and after 6-month intervention

• Changes in the memory function at 3- and 6- month after PCI

  Changes in the memory function in the Aromatherapy group versus changes in the memory function in the placebo group. The test of Word-List Immediate and Delayed Recall will be used to access the memory.

  before and after 3- and 6-month intervention

• Changes in the executive function: semantic fluency, at 3- and 6- month after PCI

  Changes in the executive function of semantic fluency in the Aromatherapy group versus changes in the executive function in the placebo group. Animal Fluency Test will be used to access participants' semantic fluency.

  before and after 3- and 6-month intervention

• Changes in the executive function: visual attention, at 3- and 6- month after PCI

  Changes in the executive function of visual attention in the Aromatherapy group versus changes in the executive function in the placebo group. Chinese version of Trails Making Test will be used to access patients' visual attention.

  before and after 3- and 6-month intervention

• Changes in the orientation function at 3- and 6- month after PCI

  Changes in the orientation function in the Aromatherapy group versus changes in the orientation function in the placebo group. MoCA Orientation function test will be used to access the orientation function.

  before and after 3- and 6-month intervention

• The proportion of patients with mild cognitive impairment at 3- and 6- month after PCI

  The proportion of patients with mild cognitive impairment in the Aromatherapy group versus the proportion of patients with mild cognitive impairment in the placebo group. Mild cognitive impairment is measured by using different cut-off points for cognitive function scores in the Chinese version of MOCA. For participants with low, secondary, and high education levels, mild cognitive impairment is defined as having an overall cognitive function score \<19, \<22, and \<24 respectively. Low education level, secondary education level and high education level are defined as the number of years of education ≤6 years, 7-12 years and \> 12 years respectively.

  before and after 3- and 6- month intervention

Study Arms (2)

The aromatherapy arm

EXPERIMENTAL

Free aromatherapy (70% menthol and 30% propanediol). 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: Aromatherapy

The placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Aromatherapy DRUG

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.

The aromatherapy arm

Placebo DRUG

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

The placebo arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Peking University: collaborator

Related Publications (1)

• Xie W, Zheng F, Yan L, Zhong B. Cognitive Decline Before and After Incident Coronary Events. J Am Coll Cardiol. 2019 Jun 25;73(24):3041-3050. doi: 10.1016/j.jacc.2019.04.019.

  PMID: 31221251 BACKGROUND

MeSH Terms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yongxiang Wei, MD

CONTACT

86-10-84005188; Yongx_anzhen2018@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, physicians, and outcomes assessors will be blinded to treatment allocation. The sticks of aromatherapy and placebo are the same, and the smell of them is similar. In order to achieve allocation concealment, a web-based central system will automatically assign a random code for each participant. Each bottle of medicine or placebo will be labeled according to the pre-determined random code by an independent agency that does not involve any persons associated with the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Beijing Anzhen Hospital

Model Details: Randomized (two arms), double-blind, placebo-controlled intervention is proposed in this study. 660 participants undergoing PCI are anticipated to be enrolled from the Beijing Anzhen Hospital. Before hospital discharge, participants will be randomly assigned to receive aromatherapy (70% menthol and 30% propanediol) or placebo (10% menthol and 90% propanediol) after PCI for 6 months.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: September 30, 2019

Record last verified: 2019-09