Can a vibratory back massage induce neo-coronary growth? A blinded, randomized controlled pilot study protocol

Completed

Conditions: Refractory Angina (CCS anginal class 3 or 4), and/or Ischemic Heart Failure (NYHA functional class 2, 3 or 4).
Circulatory System
1. Refractory Angina 2. Ischemic Heart Failure

Registration Number: ISRCTN14619275

Lead Sponsor: Ahof Biophysical Systems Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
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. <br>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.