Coronary Artery DiseaseSAMCRONCT06025994
Standardizing the Management of Patients With Coronary Microvascular Dysfunction
A study testing MULTI-DOMAIN LIFESTILE INTERVENTION in people with Coronary Artery Disease and Microvascular Angina, run by Consorzio Futuro in Ricerca at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Microvascular Angina, Microvascular Ischemia of Myocardium
- What is being tested?
- MULTI-DOMAIN LIFESTILE INTERVENTION
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Oct 2023to 10 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial
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).
Read the detailed description
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:
- 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
- Being tested
- MULTI-DOMAIN LIFESTILE INTERVENTION
- Keywords
- angina in non obstructive coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULTI-DOMAIN LIFESTILE INTERVENTIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| STANDARD OF CARE | No intervention | Patients randomized to the control group will be managed according to current guidelines |
| MULTI-DOMAIN LIFESTILE INTERVENTION | Experimental | 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 Receives: Other: MULTI-DOMAIN LIFESTILE INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-year
Secondary outcomes (3)
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
Measured: 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.
Measured: 1-year
Clinical adverse events
Cumulative occurrence of death, and hospital admission for any cause
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start10 Oct 2023
- Primary completion10 Feb 2026
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Futuro in Ricerca
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Gianluca Campo, Principal investigator, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025994
- Sponsor's protocol ID
- 488/2023/Sper/AOUFe
- Acronym
- SAMCRO
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Caglioni S, Raisi A, Erriquez A, Piva T, Cocco M, Zerbini V, Farina J, Menegatti E, Sarti A, Mandini S, Cantone A, Grazzi N, Pavasini R, Mazzoni G, Biscaglia S, Gurgoglione FL, Lazzeroni D, Martella D, Leone AM, Grazzi G, Niccoli G, Campo G. A Multidomain Lifestyle Intervention for Invasively Confirmed ANOCA: The SAMCRO Randomized Trial. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1864-1875. doi: 10.1016/j.jcin.2026.05.021.
PubMed 42508842
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial
- ClinicalTrials.gov ID
- NCT06025994
- Acronym / sponsor ID
- SAMCRO / 488/2023/Sper/AOUFe
- Keywords
- angina in non obstructive coronary artery disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Consorzio Futuro in RicercaUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Abbott Medical Devices
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| STANDARD OF CARE | No intervention | –Patients randomized to the control group will be managed according to current guidelines |
| MULTI-DOMAIN LIFESTILE INTERVENTION | Experimental | Other: MULTI-DOMAIN LIFESTILE INTERVENTIONPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MULTI-DOMAIN LIFESTILE INTERVENTIONAll 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. | Other | MULTI-DOMAIN LIFESTILE INTERVENTION |
Primary outcome
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
3 secondary outcomes
EQ visual analogue scale
Time frame: 1-year
Beck Depression Inventory (BDI)
Time frame: 1-year
Clinical adverse events
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 42508842Caglioni S, Raisi A, Erriquez A, Piva T, Cocco M, Zerbini V, Farina J, Menegatti E, Sarti A, Mandini S, Cantone A, Grazzi N, Pavasini R, Mazzoni G, Biscaglia S, Gurgoglione FL, Lazzeroni D, Martella D, Leone AM, Grazzi G, Niccoli G, Campo G. A Multidomain Lifestyle Intervention for Invasively Confirmed ANOCA: The SAMCRO Randomized Trial. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1864-1875. doi: 10.1016/j.jcin.2026.05.021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Campo principal investigator
University Hospital of Ferrara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MULTI-DOMAIN LIFESTILE INTERVENTION in people with Coronary Artery Disease and Microvascular Angina, run by Consorzio Futuro in Ricerca at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.