Standardizing the Management of Patients with Coronary Microvascular Dysfunction (SAMCRO)

Consorzio Futuro in Ricerca

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Microvascular Angina; Microvascular Ischemia of Myocardium

Treatments: Other: MULTI-DOMAIN LIFESTILE INTERVENTION

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06025994

488/2023/Sper/AOUFe

Details and patient eligibility

About

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).

Full description

The aim of the SAMCRO trial is to determine whether a multidomain lifestyle intervention improves angina status and quality of life in ANOCA patients as compared to current standard of care.

Patients will be randomized to:

EXPERIMENTAL ARM: MULTI-DOMAIN LIFESTILE INTERVENTION

Patients will receive five different kinds of intervention:

i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling CONTROL ARM: STANDARD OF CARE Patients randomized to the control group will be managed according to current guidelines

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient admitted to hospital for chronic coronary syndrome (CCS) with indication for coronary artery angiography
• absence of obstructive coronary artery disease at invasive coronary artery angiography
• Coronary microvascular dysfunction as identified by invasive coronary physiology

Exclusion criteria

• Planned coronary revascularization
• Co-morbidity reducing life expectancy to less than 1 year
• Any factor precluding 1-year follow-up
• Prior Coronary Artery Bypass Graft (CABG) surgery
• Presence of a chronic total occlusion (CTO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

STANDARD OF CARE

No Intervention group

Description:

Patients randomized to the control group will be managed according to current guidelines

MULTI-DOMAIN LIFESTILE INTERVENTION

Experimental group

Description:

Patients will receive five different kinds of intervention: i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling

Treatment:

Other: MULTI-DOMAIN LIFESTILE INTERVENTION