The Euro-CRAFT Registry

Coronary Microvascular Disease Clinical Trial

— Euro-CRAFT  

Official title:

European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805462
• Other study ID #: CRI-080
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: September 22, 2029

Study information

• Verified date: March 2023
• Source: CoreAalst BV
• Contact: Sofie Pardaens, PhD
• Phone: 0032 53 72 42 30
• Email: sofiepardaens[@]coreaalst.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 22, 2029
• Est. primary completion date: September 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR >0.80.

• Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.

Exclusion Criteria:

• Unable to provide consent

• Unstable hemodynamics

• Ongoing chest pain.

• Previous CABG

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Microvascular Angina

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Aalst	Aalst
Netherlands	Catharina Hospital	Eindhoven
Spain	Clinica La Princesa	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
CoreAalst BV	Hexacath, France

Countries where clinical trial is conducted

Belgium,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MACCE in presence of CMD defined according to thermodilution- derived metrics	Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) in the presence of coronary microvascular dysfunction (CMD) defined according to thermodilution derived metrics (bolus and continuous).	12 months follow-up
Secondary	The presence and severity of angina according to bolus thermodilution derived index microcirculatory resistance (IMR) and coronary flow reserve (CFR)	The presence and severity of angina, assessed by the Seattle Angina Questionnaire 19 (SAQ-19) according to bolus thermodilution derived index microcirculatory resistance (IMR) and coronary flow reserve (CFR)	12 months follow-up
Secondary	The rate of MACCE according to bolus thermodilution derived IMR and CFR	the rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to bolus thermodilution derived Index Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR)	12 Months follow-up
Secondary	The presence and severity of angina according to bolus thermodilution-derived single injection IMR.	The presence and severity of angina according to bolus thermodilution-derived single injection Index Microcirculatory Resistance (IMR).	12 Months follow-up
Secondary	The rate of MACCE according to bolus thermodilution-derived single injection IMR.	The rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to bolus thermodilution-derived single injection Index Microcirculatory Resistance (IMR).	12 Months follow-up
Secondary	The severity of angina, assessed by SAQ-19 in presence of CMD defined according to individual continuous thermodilution-derived indices	The severity of angina, assessed by the Seattle Angina Questionnaire (SAQ-19) in presence of Coronary Microvascular Dysfunction (CMD) defined according to individual continuous thermodilution-derived indices (absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)	12 Months follow-up
Secondary	The rate of MACCE according to individual continuous and bolus thermodilution-derived indices	The rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to individual continuous and bolus thermodilution-derived indices (Index of Microcirculatory Resistance, absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)	12 Months follow-up
Secondary	The severity of angina, assessed by the ORBITA app, according to bolus thermodilution-derived IMR and CFR.	The severity of angina, assessed by the ORBITA app, according to bolus thermodilution-derived Index Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR).	12 Months Follow-up
Secondary	The severity of angina, assessed by the ORBITA app according to individual continuous thermodilution-derived indices	The severity of angina, assessed by the ORBITA app according to individual continuous thermodilution-derived indices (absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)	12 months Follow-up