Regression of Atherosclerosis induced by liFe chAnging Experience with psiLocybin

Conditions

Stable Ischemic Heart Disease

Brief summary

Change in the atherosclerotic plaque volume between the baseline (F2) and follow-up invasive coronary artery examination (F7) performed 365 days ± 28 days after IMP administration (F4) measured with intravascular ultrasound (IVUS).

Detailed description

Change in the composition of atherosclerotic plaques between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Reduction in the incidence of the thin-cap fibroatheroma (TCFA), between the baseline (F2) and follow-up invasive coronary artery examination (F7) performed 365 days ± 28 days after IMP administration (F4), Change in the increase of the in fibrous cap thickness measured with optical coherence tomography between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Safety evaluation (blood pressure, heart rate) of study medication

Related papers

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Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in the atherosclerotic plaque volume between the baseline (F2) and follow-up invasive coronary artery examination (F7) performed 365 days ± 28 days after IMP administration (F4) measured with intravascular ultrasound (IVUS).	—

Secondary

Measure	Time frame
Change in the composition of atherosclerotic plaques between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Reduction in the incidence of the thin-cap fibroatheroma (TCFA), between the baseline (F2) and follow-up invasive coronary artery examination (F7) performed 365 days ± 28 days after IMP administration (F4), Change in the increase of the in fibrous cap thickness measured with optical coherence tomography between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Safety evaluation (blood pressure, heart rate) of study medication	—

Measure

Time frame

Change in the composition of atherosclerotic plaques between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Reduction in the incidence of the thin-cap fibroatheroma (TCFA), between the baseline (F2) and follow-up invasive coronary artery examination (F7) performed 365 days ± 28 days after IMP administration (F4), Change in the increase of the in fibrous cap thickness measured with optical coherence tomography between the baseline (F2) and follow-up invasive coronary artery examination (F7) 365 days ± 28 days after IMP administration (F4), Safety evaluation (blood pressure, heart rate) of study medication

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Countries

Czechia

Outcome results