Myocardial Infarction Clinical Trial
Official title:
ARomatherapy for Cognitive Trajectory in Chinese After Coronary Artery Bypass Grafting (ARCTIC-CABG): a Randomized, Double-blind, Placebo-controlled Trial
The ARCTIC-CABG (Aromatherapy for Cognitive Trajectory in Chinese after Coronary Artery
Bypass Grafting) 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-Coronary Artery Bypass Grafting (CABG) patients. The study will recruit 460
patients who undergo a first-time CABG at the Department of Cardiac Surgery in Beijing Anzhen
Hospital.
Baseline information will be collected prior to CABG, all eligible participants undergoing
CABG 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 CABG) and at 3- and 6-month after
CABG. The primary outcome will be the change in overall cognitive function (MOCA score) from
baseline to 6-month after CABG.
The ARCTIC-CABG 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-CABG 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 first-time CABG.
Patient recruitment:
The study will be conducted at Beijing Anzhen Hospital. All eligible patients plan to undergo
their first-time CABG 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 CABG.
Randomization and allocation concealment:
Randomization will be conducted after CABG 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.
Masking:
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.
Interventions:
Intervention will last for 6 months. All participants will receive the standard inhalation
method training before hospital discharge. For both arms, the aromatherapy/placebo will be
given twice daily (morning and evening), each time training for 4 times with deep inhalation
for 10 seconds.
Supervisory management will be carried out through WeChat app, each day all participants will
receive reminders via WeChat through the "group assistant". By the end of the intervention,
we will collect all the rest of the medications (aromatherapy/placebo) and the total amount
of the rest medication will be assessed to evaluate patients' adherence.
Measurement
Baseline measurement including the following aspects:
1. Laboratory data including: myocardial enzyme, fasting blood glucose, glycosylated
hemoglobin, total cholesterol, low-density cholesterol, high-density cholesterol,
triglyceride, high-sensitivity c-reactive protein, creatinine, uric acid, liver function
indicators, etc.
2. Genetic testing: APOE genotype.
3. Physical examination: height, weight, blood pressure, heart rate.
4. Clinical data including: left ventricular ejection fraction, heart failure
classification, GRACE score, shock, thrombolytic therapy, myocardial infarction
classification, type of MI (ST elevation or non-ST elevation), vascular stenosis,
coronary artery calcification score, etc.
5. Assessment of olfactory function: collection of prior history of dysosmia or using
Sniffin' Sticks test to assess olfactory function.
6. Assessment of cognitive function: The Chinese version of the Montreal Cognitive
Assessment (MoCA) will be used, which is translated from the original English version
and has been reviewed and authorized by the author of the original edition (Dr. Ziad
Nasreddine). The Chinese version of MoCA has been verified in the elderly population in
China, with good reliability and validity in screening for MCI and Alzheimer's disease.
In addition, we will use internationally recognized scales to evaluate memory, executive
function and orientation. All researchers involved in the cognitive function assessment
are from the clinical research institute of Peking University, independent of the study
sponsor. All cognitive assessors have received MoCA training and obtained official
certification.
7. Assessment of depression symptom: The Center for Epidemiologic Studies Depression Scale
(CES-D) will be used to measure depression symptoms severity.
8. Surgery information: methods of anesthesia, anesthetic drugs and dosage, duration of
CABG, duration of extracorporeal circulation, time to aortic occlusion, number of
proximal anastomosis, number of distal anastomosis, etc.
9. Other information: length of stay in ICU, length of stay in general ward, discharge
medications.
Follow-up Assessment: All participants will be invited back to hospital twice at 3- and 6-
month after CABG. Cognitive functions will be assessed by the same assessors using the same
methods as baseline.
Adverse events:
During the 6-month follow-up period will be recorded, which are defined as any of the
unexpected signs (such as abnormal lab values), symptoms, or diseases, whether or not
associated with aromatherapy.
Study-related adverse reactions including 1) respiratory allergy and 2) sneeze. Severe
adverse events (SAE) during follow-up are defined as any of the following:1) all-cause
mortality, 2) hospitalization for cardiovascular disease, 3) re-myocardial infarction and 4)
stroke.
Sample Size Calculation:
The total number of subjects required for this study is 230:230 patients per group. This
number was determined on the basis of the following hypotheses, with reference obtained from
the FINGER trial (Lancet 2015;385:2255-2263), Gerriets et.al (European Heart Journal
2010;31:360-368) and other related observational studies.
1. A decrease of 0.4 Z-score with a standard deviation of 0.5 at 6-month post-CABG in the
control group
2. Intervention of aromatherapy will reduce the overall cognitive decline by 40%, that is a
decrease of 0.24 Z-score at 6-month post-CABG in the intervention group.
3. α risk of 5% and β risk of 10%
4. the maximum lost to follow-up rate:10%
Statistical Analysis:
The principal analysis will be a modified intention-to-treat (ITT) analysis on patients with
at least one follow-up included in the study. The primary and continuous secondary outcomes
are repeated measures, and linear mixed models will be used for analysis. All continuous
outcomes will be standardized according to the mean and standard deviation of their baseline
values, and z-score of each variable will be obtained. Modified Poisson regression analysis
will be used for binary secondary outcomes.
Sensitivity analyses include: 1) ITT analysis including all participants, with missing data
being imputed by using multiple imputation method. 2) Only include patients with both
follow-up measurements. 3) For the primary outcome, we will also test if the intervention
effect is modified by baseline characteristics.
Statistical analyses will be carried out using the SAS Enterprise Guide 7.13 (SAS Institute
Inc, Cary, NC)
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