Background of the CAST Trial:
Heart infarction often leads to reduced heart function called “ischemic cardiomyopathy”. Reduced heart function causes limited physical capacity and thereby often severe limitation of everyday life – including shortness of breath, early exhaustion, leg edema and other symptoms.
Current treatment options of heart infarction include besides medical therapy the revascularization of a diseased blood vessel by bypass surgery or interventional stent implantation. These strategies do preserve the residual heart function but cannot improve it. Therefore regenerative treatment strategies are needed.
The purpose of the CAST Trial:
Several innovative treatment strategies have been proven during the last decades (e.g. stem cell or gene therapy). However, none of them has gained broad clinical use due to technical issues or lack in effectiveness.
Therefore, the investigators of the CAST Trial aim to prove a new regenerative option for the improvement of the heart function in addition to bypass surgery. Namely, this is cardiac shockwave therapy. It has been investigated for more than ten years in numerous pre-clinical experiments and has already been proven safe in a human pilot trial including 10 patients.
What is Shockwave Therapy:
Shockwaves are sound-pressure waves used in medicine since the early 80s. Therefore, this is a well-established clinical therapy which is in routine use for the treatment of bone, tendon and wound problems. Regenerative effects are well-described and the working mechanism as well as the more than favorable side-effect profile are intensively investigated. In the CAST Trial shockwaves at low energy are applied directly to the heart muscle when the bypass surgery has already been performed. The heart at this time is still beating on circulatory support by the heart-lung-machine to avoid any safety issues.
Which patients are enrolled into the trial:
Patients with reduced heart function (ejection fraction ≤40%) after a heart infarction in need of bypass surgery can be included into the study.
The follow-up period is one year and includes a couple of clinical investigations that also guarantee for the patient’s security and optimal postoperative care.