Ischemic heart disease and its acute form, myocardial infarction (MI), are among the most common and dangerous conditions affecting millions of people globally. In the Czech Republic, approximately 1 million people are being treated for IHD. Each year, 25,000 people are hospitalized due to MI, with about 1,000 (4%) dying as a result. Another 34,000 are hospitalized annually with chronic forms of IHD. Despite the Czech Republic having one of the world’s best systems for diagnosing and treating IHD, the global number of patients continues to rise, even in some developed countries.
A Revolutionary Approach to Reducing Risk Factors
Under the auspices of the aforementioned institutions, the RAFAEL study is now being started in the Czech Republic. It is the first study of its kind financed by INTER-ACTION, a European project focused on EU-US cooperation, and further supported by GES. It is also the first study globally which evaluates the effect of psychedelics on cardiology patients – completely outside of psychiatric indications. This represents a totally new approach to the potential treatment of IHD.
The primary objective of the study is to observe changes in the volume of atherosclerotic plaques using the most advanced invasive coronary imaging methods, both at baseline and again 12 months after inclusion in the study. During this period, patients will undergo psilocybin-assisted psychotherapy focused on lifestyle change and improving overall life satisfaction. Secondary objectives include monitoring changes in plaque composition, reduction of chronic inflammation, and improvement in the overall cardiovascular risk profile.
Dr. Tomáš Kovárník, leader of Interventional Cardiology at the General University Hospital in Prague and the supervisor of the study, explains: “Ischemic heart disease is one of the most common causes of death in our population. Despite preventive measures, we have not yet been able to halt its progression or prevent future cardiac events. One potential reason is the overlooked impact of chronic stress – a major risk factor. We believe psychedelic-assisted psychotherapy may offer a new path to improving the treatment of ischemic heart disease and overall patient health.”
Addressing Undervalued Risk Factors
The RAFAEL study proposes a revolutionary approach to treating IHD by addressing risk factors that have been largely underestimated – such as chronic stress, intense emotional experiences, and long-term irritability. These can lead to increased blood pressure, higher risk of atherosclerosis (hardening of the arteries), and ultimately a greater chance of IHD and heart attacks. Physicians hope that psilocybin-assisted therapy could offer a more effective way to address these issues compared to traditional psychotherapeutic methods.
Study Design and Objectives
RAFAEL is a randomized, double-blind phase IIa study that will enroll 60 patients aged 18 to 75 with diagnosed stable ischemic heart disease. Participants will be randomly assigned to two groups – one receiving 25 mg of psilocybin, the second 5 mg of midazolam (as a placebo). The goal is to demonstrate regression in the volume of atherosclerotic plaques and further improvements in both cardiovascular and psychological parameters.
The study aims to find out whether psychedelic therapy can bring long-term positive impacts on patients’ lives – especially in terms of overall quality of life, well-being, stress resilience, and potentially even personality traits. These mechanisms could ultimately lead to better prognoses for patients with IHD.
Dr. Tomáš Páleníček, one of the study’s co-leaders and a leading Czech psychiatrist, adds: “If we achieve positive results, this could revolutionize our approach to cardiovascular disease treatment, as one of the primary consequences of chronic stress.”
Destigmatizing Psychedelics
“This study is a first step toward recognizing psychedelics not only as a tool for treating mental illness, but also as a treatment for physical conditions significantly influenced by psychosomatic factors. I believe that the results of this study could open up new potentials for improving treatment – not only for cardiovascular disease but also for other conditions affected by similar mechanisms,” concludes Dr. Páleníček.