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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06025994
Other study ID # 488/2023/Sper/AOUFe
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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