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Measuring the blood vessel density in patients with heart failure or reduced cognitive function of vascular origin: CRUCIAL

Microvascular rarefaction in vascular cognitive impairment and heart failure: CRUCIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN22301128
Enrollment
395
Registered
2020-02-12
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Microvascular dysfunction in the heart and brain, cerebral microvascular dysfunction, cardiac microvascular dysfunction, heart failure and vascular cognitive impairment Circulatory System Heart failure, vascular cognitive impairment, aortic stenosis

Interventions

Four cohorts of participants will be recruited from the three trial participating centres. Participant cohorts have either clinical HFpEF or asymptomatic cardiac structural and/or functional alteratio

Sponsors

European Commission
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The MAASTRICHT cohort 1. Cognitive complaints 2. Signs of cerebral small vessel disease on brain MRI defined as at least Fazekas grade > 1 3. < 26 on the Montreal Cognitive Assessment 4. Aged 60 to 80 years The PAMPLONA-HFpEF cohort 1. Clinical symptoms of HFpEF of hypertensive or valvular origin (classified according to the current guidelines of the European Society of Cardiology, or ESC) 2. Structural and/or functional alterations such as left ventricular hypertrophy, left atrial dilation, and diastolic dysfunction but clinical symptoms not yet developed 3. Aged 45-85 years The RELIEF-AS II cohort 1. Severe aortic stenosis 2. Suitable for aortic valve replacement surgery 3. 50 to 85 years The UCL BIRTH cohort 1. Aged 60-80 years

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or lactation 2. eGFR 50% stenosis or prior myocardial infarction 4. LVEF 50% stenosis

Design outcomes

Secondary

MeasureTime frame
1. Identification of microvascular rarefaction as a predictive disease measurement in diastolic heart failure (HFpEF) and/or vascular cognitive impairment from MRI measurements at baseline 2. Development of alternate non-invasive measurements of microvascular rarefaction or dysfunction using Glycocheck machine, circulating biomarkers and OCT-angiography measurements at baseline

Primary

MeasureTime frame
First clinical confirmation of microvascular function measurements using state-of-the-art MRI measurements at baseline in a large patient cohort

Countries

England, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026