Standardizing the Management of Patients With Coronary Microvascular Dysfunction

Coronary Artery Disease Clinical Trial

— SAMCRO  

Official title:

Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025994
• Other study ID #: 488/2023/Sper/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: September 30, 2029

Study information

• Verified date: October 2023
• Source: Consorzio Futuro in Ricerca
• Contact: Veronica Lodolini
• Phone: 0532236450
• Email: ldlvnc[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Microvascular Angina
• Microvascular Ischemia of Myocardium
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Italy	AOU Ferrara	Ferrara
Italy	AOU di Parma	Parma

Sponsors (3)

Lead Sponsor	Collaborator
Consorzio Futuro in Ricerca	Abbott Medical Devices, Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Clinical adverse events	Cumulative occurrence of death, and hospital admission for any cause	1-year