Clinical trial NCT05805462: The Euro-CRAFT Registry
Official title: European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Microvascular Disease
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
Collaborators: name: Hexacath, France
First posted: 2023-04-10
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients in whom physiological assessment of the microcirculatory function including continuous coronary thermodilution has been performed with a Pressure-wire X within the context of routine clinical care.

Brief 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).


Eligibility criteria: 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
* Moderate to severe valvular heart disease
* Uncontrolled or recurrent ventricular tachycardia.
* Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
* Comorbidity with life expectancy \<= 2 years.
* Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
* Subject is currently participating in another investigational drug or device clinical study.
* Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Primary outcomes:
measure: The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Relationship between MACCE's and each thermodilution- derived metrics of microvascular function
timeFrame: 12 months follow-up
measure: Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function
timeFrame: 12 months follow-up
measure: Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function
timeFrame: 12 months follow-up
measure: Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
timeFrame: 12 months follow-up
measure: To determine cut-off values of thermodilution-derived indices
timeFrame: 12 months follow-up
measure: To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD)
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Copenhagen
country: Denmark
facility: Righospitalet
city: Mainz
country: Germany
facility: University of Mainz
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Nijmegen
country: Netherlands
facility: Radboud Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia, University of Belgrade
city: Cadiz
country: Spain
facility: University Hospital Puerta del Mar
city: Madrid
country: Spain
facility: Clinica La Princesa
city: Madrid
country: Spain
facility: San Carlos Hospital
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Essex
country: United Kingdom
facility: Basildon Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Imperial College
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital, King's College
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
Study officials:
References: