Standardizing the Management of Patients with Coronary Microvascular Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2029-02-04

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).

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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

Conditions

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Coronary Artery Disease Microvascular Angina Microvascular Ischemia of Myocardium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The investigators in charge of follow-up visits and questionnaire collections will be different from investigators in charge of recruitment, baseline questionnaires collection and randomization procedure. The investigators in charge of follow-up procedures will be completely blinded to the randomization, as well as patient identifying information. Regarding clinical outcomes, an independent Clinical Event Committee (CEC) will adjudicate all endpoints. The CEC members and the CEC management team will be completely blinded to the randomization, as well as patient identifying information. Other measures to avoid or minimize bias introduced by the open-label design will include intent-to-treat principles of analysis and use of objective measures for endpoint classification.

Study Groups

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STANDARD OF CARE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

MULTI-DOMAIN LIFESTILE INTERVENTION

Intervention Type OTHER

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.

Interventions

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MULTI-DOMAIN LIFESTILE INTERVENTION

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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No