Primary end points

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The primary objective, primary endpoint, of the study is to demonstrate the efficacy of the gene therapy to improve exercise capacity and relief of angina pectoris symptoms 6 months after the treatment as measured by a 6 minute walking test. This endpoint has been selected according to European Medicines Agency (EMA) guidelines and scientific advice from the Finnish Medicines Agency (FIMEA) and will be measured by assessment of the patient's angina score.

 

Secondary end points

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Secondary endpoints are efficacy of the gene transfer to increase myocardial perfusion, measured by quantitative PET perfusion at rest and adenosine stress, and cardiac function assessed at 6 months after the gene transfer. In addition, at 6 and 12 months timepoints the subjective improvement in symptoms (CCS class), quality of life using the EQ-5, SF-36 questionnaire, the use of angina pectoris medication, side effects, hospital admission or any complications due to coronary artery disease or hospital admissions due to any other reason will be evaluated. Functional capacity studied by the 6-minute walk test at 12 months will also be used as a secondary endpoint. In addition, safety of the procedure will be analysed.