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NCT06025994: SAMCRO
Standardizing the Management of Patients With Coronary Microvascular Dysfunction
NA trial testing MULTI-DOMAIN LIFESTILE INTERVENTION in Coronary Artery Disease in 123 participants. Participants enrolled and being followed up; not accepting new ones.
10 February 2026
Quick facts
| Lead sponsor | Consorzio Futuro in Ricerca |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 123 |
| Start date | 10 October 2023 |
| Primary completion | 10 February 2026 |
| Estimated completion | 10 February 2029 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- MULTI-DOMAIN LIFESTILE INTERVENTION
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Microvascular Angina — all drugs for Microvascular Angina →
- Microvascular Ischemia of Myocardium — all drugs for Microvascular Ischemia of Myocardium →
Sponsor
Consorzio Futuro in Ricerca
Who can join
18 and older, any sex, with Coronary Artery Disease or Microvascular Angina. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06025994
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Consorzio Futuro in Ricerca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06025994 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Consorzio Futuro in Ricerca
- Last refreshed: 19 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06025994.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing