Standardizing the Management of Patients With Coronary Microvascular Dysfunction

NCT06025994 | Active Not Recruiting DMC

• 1 other identifier: 488/2023/Sper/AOUFe
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

Microvascular Ischemia of Myocardium; Coronary Artery Disease; Microvascular Angina

Keywords

angina in non obstructive coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

  1-year

Secondary Outcomes (3)

• EQ visual analogue scale

  1-year

• Beck Depression Inventory (BDI)

  1-year

• Clinical adverse events

  1-year

Study Arms (2)

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

Other: MULTI-DOMAIN LIFESTILE INTERVENTION

Interventions

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.

MULTI-DOMAIN LIFESTILE INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Consorzio Futuro in Ricerca: lead
• Abbott Medical Devices: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (2)

AOU Ferrara

Ferrara, Ferrara, 44124, Italy

Location

AOU di Parma

Parma, Parma, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Microvascular Angina

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris

Study Officials

• Gianluca Campo

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 6, 2023
• Study Start: October 10, 2023
• Primary Completion: February 10, 2026
• Study Completion (Estimated): February 10, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

IT (2)