Myocardial Microvascular Disease in ESRD

Hospices Civils de Lyon30 enrolled

Overview

Cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (\>70%) is low. The goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. These patients routinely undergo non invasive detection of myocardial ischemia. Patient included in the study will be followed up for 2 years for major cardiovascular events. Patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. During coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of microcirculatory resistance (IMR). Comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease Myocardial Microvascular Disease

Interventions

Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wirePROCEDURE

The guide is placed in the distal segment of the coronary artery to measure instantaneously distal pressure and temperature with a tip sensor. Proximal pressure and temperature are being measured from the probe used to catheterize the coronary vessel and from the shaft of the guide. After basal measurement, intracoronary injection of 150µg of adenosine is performed to induce peripheral vasodilatation leading to hyperaemia in the vessel. Additional injection of 3mL 0.9% saline bolus at room temperature at the time of hyperaemia is performed to calculate CFR from transit mean time. FFR and CFR are being recorded at the time of hyperaemia. Subsequently IMR is being calculated from distal pressure and transit mean time. The measurements will be performed in the LAD, circumflex and right coronary arteries.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age \> 18 years with end stage renal disease under dialysis and/or scheduled for kidney or kidney + pancreatic transplantation * Having a non invasive detection of myocardial ischemia and agreeing to participate (signed informed consent document) Exclusion Criteria: Past medical history of * Acute coronary syndrome * Hypertrophic cardiomyopathy * severe aortic and/or mitral valvular disease (grade ≥ 3) * Known contraindications to adenosine injection: AV block grade ≥ 2 and/or sinoatrial block unless prior implantation of a pace maker, asthma, allergic reaction to adenosine.

Locations (1)

Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon

Bron, France

Outcomes

Primary Outcomes

Major cardiovascular events

Major cardiovascular events * Death (all cause) * Acute coronary syndromes (STEMI, NSTEMI, UA) * New onset of stable angina * New onset of congestive heart failure or progression of previously known congestive heart failure (need for therapeutic intensification and/or hospital admission) * Cardiogenic shock * Stroke * Severe cardiac arrhythmia (FV, VT) * New onset of atrial fibrillation

Time frame: Inclusion: 1 year - Follow up: 2 years

Secondary Outcomes

Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.

Time frame: Inclusion: 1 year

Data from ClinicalTrials.gov

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