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
Conditions
Interventions
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 (hi
Sponsors
Ahof Biophysical Systems Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, United States of America
Outcome results
None listed