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

Not Applicable

• 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

• Registration Number: ISRCTN22301128
• Lead Sponsor: European Commission

Brief Summary

2023 Protocol article in https://doi.org/10.1159/000529067 (added 03/05/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-12
• Last Update Posted: 27 May 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 395

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

1. Pregnancy and/or lactation
2. eGFR <30ml/min
3. Magnetic resonance incompatible devices
4. Inability to complete the study
The MAASTRICHT cohort
1. Non-vascular cause for the cognitive deficit. Clinical evidence of neurodegenerative disease(s) such as Alzheimer’s Disease, frontotemporal dementia, Lewy Body disease, or hypokinetic rigid syndrome
2. Lack of independence in daily living and/or a clinical dementia rating =1.0
3. Lack of capacity to consent to participate
The PAMPLONA-HFpEF cohort
1. Severe bone or metabolic disease
2. Active neoplasia
3. Flow-limiting coronary artery disease >50% stenosis or prior myocardial infarction
4. LVEF <50%.
The RELIEF-AS II cohort
1. Flow-limiting coronary artery disease >50% stenosis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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<br>2. Development of alternate non-invasive measurements of microvascular rarefaction or dysfunction using Glycocheck machine, circulating biomarkers and OCT-angiography measurements at baseline