NCT06025994Active, not recruiting
Standardizing the Management of Patients With Coronary Microvascular Dysfunction
Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 15 Aug 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Consorzio Futuro in Ricerca
- Diseases
- Coronary artery disease
- NCT number
- NCT06025994
What you commit to
- Study type: Interventional
- Participants enrolled: 123
- From 10 Oct 2023 to the primary completion date, 10 Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Coronary Artery Bypass Graft (CABG) surgery
Other
- Planned coronary revascularization
- Co-morbidity reducing life expectancy to less than 1 year
- Any factor precluding 1-year follow-up
- Presence of a chronic total occlusion (CTO)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| AOU di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
Related publications
- A Multidomain Lifestyle Intervention for Invasively Confirmed ANOCA: The SAMCRO Randomized Trial.JACC Cardiovasc Interv · 2026 · PMID 42508842
This page is information, not medical advice. Discuss any trial with your doctor.