Clinical trial NCT01291771: Myocardial Microvascular Disease in ESRD
Official title: Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Myocardial Microvascular Disease
Keywords: End stage renal disease
myocardial microvascular disease
cardiorenal syndrome
coronary flow reserve
index of microvascular resistance
Patients with end stage renal disease scheduled or not for kidney or kidney + pancreatic transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major cardiovascular events
timeFrame: Inclusion: 1 year - Follow up: 2 years
Secondary outcomes:
measure: Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.
timeFrame: Inclusion: 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Denis ANGOULVANT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bejan-Angoulvant T, Bergerot C, Juillard L, Mezergues A, Morelon E, Pouteil-Noble C, Andre-Fouet X, Angoulvant D. Myocardial microvascular disease and major adverse cardiovascular events in patients with end-stage renal disease: rationale and design of the MICROCARD study. Nephrol Dial Transplant. 2012 Jul;27(7):2886-91. doi: 10.1093/ndt/gfs008. Epub 2012 Feb 17.