Standardizing the Management of Patients With Coronary Microvascular Dysfunction

Study Overview
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Brief Summary
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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
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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

Official Title
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Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial

Conditions
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Coronary Artery Disease, Microvascular Angina, Microvascular Ischemia of Myocardium

Intervention / Treatment
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* Other: MULTI-DOMAIN LIFESTILE INTERVENTION


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: STANDARD OF CARE<br>Patients randomized to the control group will be managed according to current guidelines | |
| Experimental: MULTI-DOMAIN LIFESTILE INTERVENTION<br>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 | Other: MULTI-DOMAIN LIFESTILE INTERVENTION<br>* All participants in the multi-domain lifestyle group 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) exercise training iv) dietary counselling, v) psychological intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle Angina Questionnaire | The primary efficacy endpoint is the value of Seattle Angina Questionnaire (SAQ) summary score. The SAQ-SS ranges from 0 to 100 and higher values indicate better outcome | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ visual analogue scale | The continuous value of EQ visual analogue scale (EQ-VAS). The EQ-VAS scale ranges from 0 to 100 and higher values indicate better outcome | 1-year | 
| Beck Depression Inventory (BDI) | The continuous value of Beck Depression Inventory (BDI). BDI score ranges from 0 to 63. Higher scores indicate greater depressive severity. | 1-year | 
| Clinical adverse events | Cumulative occurrence of death, and hospital admission for any cause | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angina in non obstructive coronary artery disease