Standardizing the Management of Patients With Coronary Microvascular Dysfunction

The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60 months. The study endpoints will be the improvement of angina status and quality of life as assessed by validated questionnaires at one year. All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) dietary counselling, ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv) exercise training and v) psychological intervention. Patients randomized to the control group will be managed according to current guidelines. The angina status will be assessed by the Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).

NCT Number	NCT06025994
Lead Sponsor	Consorzio Futuro in Ricerca Collaborators: Università degli Studi di Ferrara, Abbott Medical Devices
Conditions	Coronary Artery Disease, Microvascular Angina, Microvascular Ischemia of Myocardium
Enrollment	123 participants
Start Date	2023-10-10
Primary Completion	2026-02-10 (estimated)
Study Completion	2029-02-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-19