StAndardizing the Management of patients with coronary miCROvascular dysfunction: rationale and design of the SAMCRO trial

BACKGROUND: Angina with no obstructive coronary artery disease (ANOCA) is an increasingly recognized clinical condition, frequently attributable to coronary microvascular dysfunction (CMD). Patients with ANOCA experience markedly impaired quality of life (QoL). While most current studies focus on disease prevalence, diagnostic strategies, and pharmacological therapy, limited data exist on interventions targeting physical limitation, psychological distress, and overall QoL. We describe the design of a dedicated trial addressing this unmet clinical need through a multidomain lifestyle intervention. METHODS: The Standardized Management of Patients with Coronary Microvascular Dysfunction (SAMCRO) trial is a prospective, randomized, multicenter, open-label study with blinded endpoint adjudication. Patients presenting with angina and invasively confirmed CMD, in the absence of obstructive coronary artery disease, will be randomized to either a multidomain lifestyle intervention or standard care. The intervention comprises five domains: 1) intensive management of cardiovascular and metabolic risk factors; 2) endotype-guided medical therapy; 3) structured exercise training; 4) individualized dietary counseling; and 5) psychological support. The primary efficacy endpoint is the Seattle Angina Questionnaire (SAQ) summary score at 12 months. Secondary endpoints include individual SAQ domains, global QoL, anxiety and depression scores, adherence to the intervention, all-cause and cardiovascular mortality, and hospitalizations for any cause. The planned sample size is 120 patients. CONCLUSIONS: The SAMCRO trial will evaluate whether a comprehensive multidomain lifestyle intervention, successfully implemented in other cardiovascular conditions, can improve symptoms, functional capacity, mood, and QoL in patients with ANOCA compared with standard care.