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Active, Not Recruiting

NCT Number: NCT06025994

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Microvascular Angina Microvascular Ischemia of Myocardium Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Ferrara, Ferrara, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MULTI-DOMAIN LIFESTILE INTERVENTION

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.

Primary outcomes

  1. Seattle Angina Questionnaire

    Time frame: 1-year

    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

Secondary outcomes

  1. EQ visual analogue scale

    Time frame: 1-year

    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

  2. Beck Depression Inventory (BDI)

    Time frame: 1-year

    The continuous value of Beck Depression Inventory (BDI). BDI score ranges from 0 to 63. Higher scores indicate greater depressive severity.

  3. Clinical adverse events

    Time frame: 1-year

    Cumulative occurrence of death, and hospital admission for any cause

Sponsors and collaborators

Lead sponsor

Consorzio Futuro in Ricerca

Other

Collaborators

  • Abbott Medical Devices
  • Università degli Studi di Ferrara

Registry information

Official study title

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

Acronym: SAMCRO

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Sep 6, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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