Topics

ARomatherapy for Cognitive Trajectory in Chinese After Coronary Artery Bypass Grafting

2019-09-30 07:07:00 | BioPortfolio

Summary

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 or placebo (perfume sniffing). 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.

Description

The ARCTIC-CABG trial has two objectives:

The primary objective is to evaluate the efficacy of Aromatherapy (menthol inhalation) 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 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 (menthol inhalation) or placebo (perfume inhalation). Each Sniffin' stick of menthol 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 menthol and the perfume placebo are the same, and the smell of menthol and placebo 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 menthol/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 (menthol/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 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)

Study Design

Conditions

Coronary Artery Bypass Grafting

Intervention

menthol, perfume placebo

Status

Not yet recruiting

Source

Beijing Anzhen Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-30T07:07:00-0400

Clinical Trials [3682 Associated Clinical Trials listed on BioPortfolio]

Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting

The purpose of this study is to determine whether doxycycline(Periostat)at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery w...

Resynchronization Surgery Combined Unified Efficacy

The purpose of the study is to compare survivability of the patients with ischemic heart failure LVEF ≤ 35% after coronary artery bypass grafting or coronary artery bypass grafting combi...

Aspirin and Plavix Following Coronary Artery Bypass Grafting

The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering th...

Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous interventio...

TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal ...

PubMed Articles [4626 Associated PubMed Articles listed on BioPortfolio]

Multiple Coronary Artery Bypass Grafting for Kawasaki Disease-Associated Coronary Artery Disease.

Although coronary artery bypass grafting (CABG) is the preferred choice for advanced Kawasaki disease (KD)-associated coronary artery disease, graft design such as number of grafts or type of conduits...

No significant association between obesity and long-term outcome of coronary artery bypass grafting.

 Our objective was to investigate long-term outcomes of obese patients undergoing coronary artery bypass grafting (CABG) in Iceland.

Do women benefit more than men from off-pump coronary artery bypass grafting?

Outcomes after coronary artery bypass grafting (CABG) are worse in women than in men. This study aims to investigate whether off-pump coronary artery bypass (OPCAB) surgery improves the outcomes in wo...

Midterm outcomes for isolated coronary artery bypass grafting in octogenarians.

An increase in the life expectancy of the general population has led to heightened numbers of elderly patients in need of coronary artery bypass grafting (CABG). Surgical revascularization in octogena...

Impact of Coronary Collateral Circulation of Perioperative Myocardial Damage in High-Risk Patients Undergoing Coronary Artery Bypass Grafting Surgery.

Coronary collateral circulation (CCC) is a small vascular formation that allows the connection between the different parts of an epicardial vessel or other vessels. The presence of collateral circulat...

Medical and Biotech [MESH] Definitions

Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.

Abdominal artery that follows the curvature of the stomach. The right gastroepiploic artery is frequently used in CORONARY ARTERY BYPASS GRAFTING; MYOCARDIAL REVASCULARIZATION, and other vascular reconstruction.

Coronary artery bypass surgery on a beating HEART without a CARDIOPULMONARY BYPASS (diverting the flow of blood from the heart and lungs through an oxygenator).

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

Inferior and external epigastric arteries arise from external iliac; superficial from femoral; superior from internal thoracic. They supply the abdominal muscles, diaphragm, iliac region, and groin. The inferior epigastric artery is used in coronary artery bypass grafting and myocardial revascularization.

More From BioPortfolio on "ARomatherapy for Cognitive Trajectory in Chinese After Coronary Artery Bypass Grafting"

Quick Search

Relevant Topic

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial