Myocardial Microvascular Disease in ESRD

End Stage Renal Disease Clinical Trial

— MICROCARD  

Official title:

Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01291771
• Other study ID #: 2010.611
• Status: Terminated
• Phase: N/A
• First received: February 7, 2011
• Last updated: January 15, 2015
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Myocardial Microvascular Disease

Intervention

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

Locations

Country	Name	City	State
France	Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inclusion: 1 year - Follow up: 2 years	No
Secondary	Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.		Inclusion: 1 year	Yes