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NCT Number: NCT07608679

Estimation of the Prevalence of Microcirculatory Dysfunction in Uremic Cardiopathy Among Dialysis Patients

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000, France

Location contact

Grégoire COUVRAT-DESVERGNES

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transthoracic ultrasound at rest

Diagnostic Test

Transthoracic ultrasound at rest

Cardiological stress test

Diagnostic Test

Left to the discretion of the centre: dobutamine echocardiography or myocardial scintigraphy.

Coronary angiography

Diagnostic Test

Even even if the stress test comes back normal (these tests appear to be less effective at diagnosing microcirculatory abnormalities)

Primary outcomes

  1. Percentage of patients with microcirculatory heart disease (i.e. microvascular dysfunction or microvascular vasospasm) identified during coronary angiography

    Time frame: Cardiac examinations to be carried out within 8 to 10 weeks of enrolment

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé MOREAU

CONTACT

[email protected]

251446327 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: PRE-COCO

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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