Standardizing the Management of Patients With Coronary Microvascular Dysfunction (SAMCRO)

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Microvascular Angina; Microvascular Ischemia of Myocardium
• Intervention / Treatment: Other: MULTI-DOMAIN LIFESTILE INTERVENTION

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica Lodolini; Phone Number: +39 0532236450; Email: ldlvnc@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Recruiting
    • AOU Ferrara
    • Contact: Simone Biscaglia
  • Parma, Italy
    • Not yet recruiting
    • AOU di Parma
    • Contact: Giampaolo Niccoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: STANDARD OF CARE; Patients randomized to the control group will be managed according to current guidelines
Experimental: 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	Other: MULTI-DOMAIN LIFESTILE INTERVENTION; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1-year
Clinical adverse events	Cumulative occurrence of death, and hospital admission for any cause	1-year

Collaborators and Investigators

• Sponsor: Consorzio Futuro in Ricerca
• Collaborators: Università degli Studi di Ferrara; Abbott Medical Devices
• Investigators: Principal Investigator: Gianluca Campo, University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 2, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: angina in non obstructive coronary artery disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Microvascular Angina
• Other Study ID Numbers: 488/2023/Sper/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No