Clinical trial NCT06025994: Standardizing the Management of Patients with Coronary Microvascular Dysfunction
Official title: Standardizing the Management of Patients with Coronary Microvascular Dysfunction: the SAMCRO Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Microvascular Angina
Microvascular Ischemia of Myocardium
Keywords: angina in non obstructive coronary artery disease
Lead sponsor: Consorzio Futuro in Ricerca
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
name: Abbott Medical Devices
First posted: 2023-09-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The " Standardizing the Management of patients with Coronary Microvascular Dysfunction (SAMCRO) " trial is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of endpoints (PROBE).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: 1-year
Secondary outcomes:
measure: EQ visual analogue scale
timeFrame: 1-year
measure: Beck Depression Inventory (BDI)
timeFrame: 1-year
measure: Clinical adverse events
timeFrame: 1-year
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: AOU Ferrara
city: Parma
country: Italy
facility: AOU di Parma
Study officials:
affiliation: University Hospital of Ferrara
name: Gianluca Campo
role: PRINCIPAL_INVESTIGATOR
References: