Myocardial Microvascular Disease in ESRD (MICROCARD)

Civil Hospices of Lyon

Status: Terminated

Conditions: Myocardial Microvascular Disease; End Stage Renal Disease

Treatments: Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire

Study type: Interventional

Funder types: Other

Identifiers

NCT01291771

2010.611

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

comparator

Other group

Description:

One group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years

Treatment:

Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire

coronary angiography group

Experimental group

Description:

One group of patients with myocardial ischemia on non invasive testing will undergo coronary angiography and measure of FFR + CFR to detect myocardial microvascular disease

Treatment:

Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire