ARomatherapy for Cognitive Trajectory in Chinese After Percutaneous Coronary Intervention (ARCTIC-PCI): a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 660
- 主要终点
- Changes in the executive function: visual attention, at 3- and 6- month after PCI
研究概览
简要总结
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.
详细描述
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 patients. The secondary objective is to evaluate the safety of aromatherapy. We hypothesize that the aromatherapy will result in improved 6- month cognitive functions compared to the placebo (10% menthol and 90% propanediol) among patients accepted a PCI.
Patient recruitment:
The study will be conducted at Beijing Anzhen Hospital. All eligible patients plan to undergo their PCI will be screened for eligibility, written informed consent need to be provided. For patients who meet all inclusion and exclusion criteria, baseline assessment will be carried out 1 to 3 days prior to the PCI.
Randomization and allocation concealment:
Randomization will be conducted after PCI and before hospital discharge. To ensure concealment of the treatment allocation, randomization will be performed by a web-based IT system. All eligible participants will be randomly assigned in a 1:1 ratio to receive aromatherapy (70% menthol and 30% propanediol) or placebo (10% menthol and 90% propanediol). Each sniffin' stick of aromatherapy 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The aromatherapy arm
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.
干预措施: Aromatherapy (Drug)
The placebo arm
Free placebo (10% menthol and 90% propanediol) will be provided for 6 months. The specific method is the same as aromatherapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the executive function: visual attention, at 3- and 6- month after PCI
时间窗: before and after 3- and 6-month intervention
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.
The proportion of patients with mild cognitive impairment at 3- and 6- month after PCI
时间窗: before and after 3- and 6- month intervention
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.
Changes in the overall cognitive function at 6 months after PCI
时间窗: before and after 6-month intervention
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.
Changes in the overall cognitive function at 3 months after PCI
时间窗: before and after 6-month intervention
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.
Changes in the orientation function at 3- and 6- month after PCI
时间窗: before and after 3- and 6-month intervention
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.
Changes in the memory function at 3- and 6- month after PCI
时间窗: before and after 3- and 6-month intervention
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.
Changes in the executive function: semantic fluency, at 3- and 6- month after PCI
时间窗: before and after 3- and 6-month intervention
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.
次要结局
未报告次要终点
研究者
Wei Yongxiang
Director of Beijing Anzhen Hospital
Beijing Anzhen Hospital