The Euro-CRAFT Registry

NCT05805462 | Active Not Recruiting

• 1 other identifier: CRI-080
• Study Type: observational
• Target: 671
• Locations: 8 countries
• Sites: 19

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).

Conditions

Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (1)

• The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.

  Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).

  12 months follow-up

Secondary Outcomes (6)

• Relationship between MACCE's and each thermodilution- derived metrics of microvascular function

  12 months follow-up

• Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function

  12 months follow-up

• Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function

  12 months follow-up

• Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.

  12 months follow-up

• To determine cut-off values of thermodilution-derived indices

  12 months follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CoreAalst BV: lead
• Hexacath, France: collaborator

Study Sites (19)

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Righospitalet

Copenhagen, Denmark

Location

University of Mainz

Mainz, Germany

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Radboud Hospital

Nijmegen, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

University Clinical Center of Serbia, University of Belgrade

Belgrade, Serbia

Location

University Hospital Puerta del Mar

Cadiz, Spain

Location

Clinica La Princesa

Madrid, Spain

Location

San Carlos Hospital

Madrid, Spain

Location

University Hospital Lausanne

Lausanne, Switzerland

Location

Royal United Hospital Bath NHS Foundation Trust

Bath, United Kingdom

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

Basildon Hospital

Essex, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Imperial College

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

St. Thomas Hospital, King's College

London, United Kingdom

Location

Oxford University Hospitals

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 10, 2023
• Study Start: September 22, 2022
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NL (3); DE (1); SE (1); DK (1); BE (1); ES (3); GB (8)