Estimation of the Prevalence of Microcirculatory Dysfunction in Uremic Cardiopathy Among Dialysis Patients
PRE-COCO
1 other identifier
interventional
30
1 country
1
Brief Summary
Patients with end-stage renal disease have a high burden of cardiovascular mortality, yet ischemic heart disease is often asymptomatic and difficult to diagnose in this population. Recent data suggest that microvascular coronary dysfunction may contribute significantly to myocardial ischemia in dialysis patients, but its true prevalence remains unknown. This study aims to evaluate microcirculatory coronary impairment in hemodialysis patients using invasive coronary angiography with measurement of coronary flow reserve (CFR), index of microcirculatory resistance (IMR). The study will also describe the clinical and biological characteristics associated with microvascular dysfunction in this population, in order to better understand the mechanisms of uremic cardiomyopathy and improve cardiovascular risk stratification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
May 27, 2026
May 1, 2026
9 months
May 20, 2026
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with microcirculatory heart disease (i.e. microvascular dysfunction or microvascular vasospasm) identified during coronary angiography
Cardiac examinations to be carried out within 8 to 10 weeks of enrolment
Interventions
Transthoracic ultrasound at rest
Left to the discretion of the centre: dobutamine echocardiography or myocardial scintigraphy.
Even even if the stress test comes back normal (these tests appear to be less effective at diagnosing microcirculatory abnormalities)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Patients who have been on haemodialysis for at least 6 months
- Elevated troponin levels \> 40 ng/L in a sample taken whilst the patient was in a stable condition, dated within the last 3 months
- Patients capable of understanding the protocol and who have given their written informed consent to participate in the research
- Patients registered with the National Health Service or eligible for it
You may not qualify if:
- Age \> 90 years
- Patient undergoing daily home haemodialysis
- Symptomatic stage 3 or 4 peripheral arterial disease
- Severe hypertrophic cardiomyopathy (genetic or amyloid)
- Severe valvular heart disease leading to left ventricular remodelling (surgically contraindicated severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation)
- Hospitalisation for decompensation/acute heart failure within the last month
- Acute coronary syndrome and any coronary artery disease requiring angioplasty and/or stent implantation within the last 3 months
- Contraindication to METHERGIN and DOBUTAMINE
- Patients participating in another clinical research protocol that may affect the research objectives
- Patients already included in the study
- Patients under guardianship, curatorship or deprived of their liberty
- Patients under an activated future protection order
- Patients under family authorisation
- Patient under judicial protection
- Pregnant patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grégoire COUVRAT-DESVERGNES
Centre Hospitalier Departemental Vendee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2026
First Posted
May 27, 2026
Study Start (Estimated)
September 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share