ARomatherapy for Cognitive Trajectory in Chinese After Coronary Artery Bypass Grafting

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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 (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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Anzhen Hospital
• Collaborator: Peking University
• Treatments: Menthol

Criteria

Inclusion Criteria:

1. Men and women aged between 50 and 75 years old.

2. Undergoing CABG for the first time.

3. Willing to come to hospital at 3- and 6- month after CABG.

4. Signed informed consent.

Exclusion Criteria:

1. Emergency patients.

2. Prior history of cardiac surgery other than CABG.

3. Prior history of heart failure.

4. Prior history of atrial fibrillation.

5. Prior history of allergic rhinitis, sinusitis, asthma and COPD.

6. Deafness, mental illness including severe depression, and inability to communicate properly.

7. Prior history of stroke.

8. Prior history of brain tumor, traumatic brain injury, or other brain surgery.

9. Relatives of researcher or management personnel.

10. Family members been enrolled in the study.

11. Known mild cognitive impairment or dementia.

12. Mild cognitive impairment and dementia identified by cognitive function assessment before CABG.

13. Prior history of smell disorder or decreased/loss of olfactory functions assessed by the Sniffin' Sticks test.