European microCirculatory Resistance and Absolute Flow Team-The Euro-CRAFT Registry Prospective evaluation of the impact of coronary themodilution on clinical outcomes in chronic coronary syndromes

European microCirculatory Resistance and Absolute Flow Team-The Euro-CRAFT Registry Prospective evaluation of the impact of coronary themodilution on clinical outcomes in chronic coronary syndromes - Euro-CRAFT registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56717

Enrollment

100

Registered

2024-04-09

Start date

2024-06-03

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic coronary syndromes disease of the small coronaries

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: . Age 3 times the ULN. 9. Comorbidity with life expectancy

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the rate of major adverse cardiac and cerebrovascular events at one year (MACCE - defined as cardiovascular death, myocardial infarction, revascularization, angina and heart failure-related hospitalizations, and stroke) between patients with and without CMD based on MRR at 1 year follow-up.	—

Secondary

Measure	Time frame
Main Secondary endpoints: 1. Relationship between MACCE*s and each thermodilution derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 2. Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 3. Relationship between the presence and severity of angina, assessed by the Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 4. Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration. 5. To determine cut-off values of thermodilution-derived indices. 6. To assess the prevalence of CMD based on MRR in patients with angina and non-obstructive coronary artery disease (NOCAD).	—

Measure

Time frame

Main Secondary endpoints: 1. Relationship between MACCE*s and each thermodilution derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 2. Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 3. Relationship between the presence and severity of angina, assessed by the Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and CFR). 4. Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration. 5. To determine cut-off values of thermodilution-derived indices. 6. To assess the prevalence of CMD based on MRR in patients with angina and non-obstructive coronary artery disease (NOCAD).

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Countries

Netherlands

Outcome results