Myocardial Microvascular Disease in ESRD

Not Applicable

Terminated

• Conditions: End Stage Renal Disease; Myocardial Microvascular Disease
• Interventions: Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire

• Registration Number: NCT01291771
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2014-01
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coronary angiography group	Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire	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
comparator	Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire	One group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events	Inclusion: 1 year - Follow up: 2 years	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

Secondary Outcome Measures

Name	Time	Method
Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.	Inclusion: 1 year

Trial Locations

Locations (1)

Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon; 🇫🇷 Bron, France