The MUST-ECP Trial
In 1995, Vasomedical began a large, randomized, controlled and double-blinded clinical trial, Multicenter Study of Enhanced External Counterpulsation (MUST- ECP) at seven leading university hospitals in the United States to confirm the patient benefits observed in the open studies conducted at SUNY-Stony Brook and to provide definitive scientific evidence of ECP therapy’s effectiveness. MUST-ECP was completed in July 1997 and the results were presented at the annual Scientific Sessions of the American Heart Association in November 1997 and the American College of Cardiology in March 1998. The Journal of the American College of Cardiology (JACC), a major peer-reviewed medical journal, published the results of the MUSTECP trial in June 1999.
This 139 patient study, which included a sham-ECP therapy control group, showed that ECP therapy was a safe and effective treatment option for patients suffering from angina pectoris, including those on maximal medication and for whom invasive revascularization procedures were no longer an option. The results of the MUST-ECP study confirmed the clinical benefits described in earlier studies, namely a decline in anginal frequency and a decrease in exercise-induced signs of myocardial ischemia.
In 2000, Vasomedical completed a quality of life sub-study with patients that participated in MUST-ECP. Two highly regarded and standardized means of measurement were used to gauge changes in patients’ outlook and ability to participate in normal daily activities during the treatment phase and for up to 12 months after treatment. Results of this study, which have been presented at major scientific meetings and published in the January 2002 Journal of Investigative Medicine, show that the group of patients receiving ECP therapy enjoyed significantly improved aspects of health-related quality of life compared to those who received sham treatment.