The Euro-CRAFT Registry

Launched by COREAALST BV · Mar 27, 2023

Keywords

ClinConnect Summary

The Euro-CRAFT Registry is a research study aimed at better understanding coronary microvascular disease, which affects the small blood vessels in the heart and can cause chest pain, known as angina. This study will involve patients who have chest pain but do not have significant blockages in their main coronary arteries. Participants will be assessed using a specific test called continuous thermodilution to evaluate how well their heart's small blood vessels are functioning. Throughout the study, participants will fill out questionnaires about their chest pain and quality of life at the beginning of the trial, and again at six months and one year later.

To be eligible for this study, participants need to be at least 18 years old and have stable chest pain. They should also have been diagnosed with non-obstructive coronary arteries, meaning their main arteries are not significantly blocked. Importantly, individuals who cannot provide consent, are having unstable heart conditions, or have ongoing chest pain are not eligible. If you decide to participate, you'll have regular check-ins for a year, with the option for additional follow-ups for up to five years, helping researchers gather valuable information to improve care for patients with similar conditions.

Gender

ALL

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.