Can a vibratory back massage induce neo-coronary growth? A blinded, randomized controlled pilot study protocol
| ISRCTN | ISRCTN14619275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14619275 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/08/2015
- Registration date
- 01/09/2015
- Last edited
- 29/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Coronary artery disease (CAD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CAD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). CAD includes a number of diseases, such as angina (pain or pressure in the chest), which is worsened by physical activity or stress. The current treatments for CAD focus on relieving the symptoms and reducing the risk of a heart attack (myocardial infarction). New treatments are emerging, using adult stem cells from patients’ own bodies to re-build heart tissue (neocardiogenesis). The aim of this study is to find out whether the use of low frequency vibration massage will help stimulate the growth of new heart tissue in patients with CAD.
Who can participate?
Adults suffering from either angina or ischemic heart disease, who have been deemed unsuitable for heart surgery.
What does the study involve?
Participants are divided into two groups, based on the condition they are suffering from. These groups are then randomly allocated into two further groups who receive different treatments daily. Those in the first group receive half hour sessions of high setting (penetrative) vibration to their upper back via the Vibro-Acoustic Therapy system. Those in the second group receive low setting (non-penetrative) sham therapy to their lower back. The extent of their heart disease and how well their hearts are functioning is measured before the therapy, immediately after, and again three and six months after the therapy.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement of the symptoms of their disorders. There are no long term risks to participants of the study, however continuously applied LFV may be a mild stressor to the heart in some cases angina and /or a sensation of shortness of breath may be temporarily brought on by the treatment.
Where is the study run from?
False Creek Surgical Centre (Canada)
When is the study starting and how long is it expected to run for?
August 2015 to August 2017
Who is funding the study?
Ahof Biophysical Systems Inc. (Canada)
Who is the main contact?
Mr Andrew Hoffman
andrew.hoffmann11@gmail.com
Contact information
Scientific
Ahof Biophysical Systems Inc.
3858 Regent Street
Burnaby, British Columbia
V5C4G8
Canada
| Phone | +1 604 779 3571 |
|---|---|
| andrew.hoffmann11@gmail.com |
Study information
| Study design | A single center prospective blinded interventional randomized controlled pilot study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Coronary Revascularization by ExtrAcorporeal Transthoracic Epi-myocardial VIBration |
| Study acronym | CREATE-VIB trial |
| Study objectives | Penetrative upper back 35 Hz sinusoidal Low Frequency Vibration massage applied daily for 30 minute sessions over a 3 month period via the VTS – 1000 Vibro-Acoustic Therapy system will stimulate neo-coronary growth, enhance myocardial perfusion, and improve clinical outcomes in Refractory Angina and/or Ischemic Heart Failure patients. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Refractory Angina (CCS anginal class 3 or 4), and/or Ischemic Heart Failure (NYHA functional class 2, 3 or 4). |
| Intervention | Thirty ischemic heart test subjects will be divided into two parallel groups matched for condition and class, where-after the groups will be randomized to receive half hour sessions of penetrative (high setting) 35 Hz vibration via the VTS – 1000 Vibro-Acoustic Therapy system to their upper back vs. non-penetrative (low setting) sham therapy. Interventions planned daily (with a minimum compliance rate of 75%) - over a 3 month period. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Stress SPECT MPI (maximal exercise) to assess myocardial perfusion by global perfusion at rest (SSS – Summed Stress Score) and stress (SRS – Summed Rest Score), pre vs. post therapy. Time to 1 mm and 2 mm ST depression, time to and degree of anginal symptoms, and functional capacity (total time on treadmill) should be additionally noted on a case by case basis. 2. Stress Echo (maximal exercise) to assess evaluation of inducible RWMAs by hypo-akinetic segment count and Wall Motion Score Index (WMSI) - pre vs. post therapy. 3. Walking test (20 to 100 meter; patient encouraged to walk as long and as brisk as possible) to assess NHYA heart failure classification and CCS anginal class- pre vs. immediate post, 3 months and 6 months post therapy. |
| Secondary outcome measures | 1) Anginal count by month long diary record (average frequency of anginal episodes per day), pre vs. immediate post, three and six months post therapy. 2) Nitroglycerine (NTG) use count by month long diary record (average frequency of NTG usage per day), pre vs. immediate post, three and six months post therapy. |
| Overall study start date | 26/08/2015 |
| Completion date | 12/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 (15 control, 15 receiving therapy) |
| Key inclusion criteria | 1. Adults (> 35 years of age) 2. Patient weight up to 120 kg 3. Stable, CCS class 3 or 4 angina pectoris, and/or NYHA functional class 2, 3 or 4 ischemic heart failure 4. A positive Exercise Treadmill Test (ETT), and at least one of a Nuclear SPECT MPI perfusion study showing evidence for reversible myocardial ischemia, and/or a Stress Echo showing at least one provoked Regional Wall Motion Abnormality (RWMA) 5. An interpretable QRS complex enabling ST analysis during stress testing (i.e. no left bundle branch block–LBBB, or paced beats during stress) 6. Ability to present for daily hospital appointments (with a minimal expected compliance of at least 75%), over a three month period 7. Patient was declined to Coronary Artery Bypass Graft (CABG) surgery and / or Percutaneous Coronary Intervention (PCI) by the attending cardiologist or surgeon, and has no plans to undertake other forms of coronary angiogenic therapy (e.g. EECP, ESMR etc.) during the study period 8. Patient has received optimized medical therapy |
| Key exclusion criteria | 1. Left bundle branch block (LBBB) 2. Paced Rhythm 3. Severe Aortic Stenosis (valve area up to 1.0 cm2) 4. Patient’s weight greater than 120 kg 5. Cannot walk on treadmill |
| Date of first enrolment | 02/01/2016 |
| Date of final enrolment | 02/01/2017 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
Vancouver, British Columbia
V5Z 1C6
Canada
Sponsor information
Industry
3858 Regent Street
Burnaby, BC
V5C4G8
Canada
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Once the study is completed data will be synthesized and written up in view to publication in a peer reviewed journal. |
| IPD sharing plan |
