Myocardial Microvascular Disease in ESRD (MICROCARD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01291771
First received: February 7, 2011
Last updated: December 13, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Myocardial Microvascular Disease
Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Major cardiovascular events [ Time Frame: Inclusion: 1 year - Follow up: 2 years ] [ Designated as safety issue: No ]

    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:
  • Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests. [ Time Frame: Inclusion: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: January 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: comparator
One group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years
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.
Experimental: coronary angiography group
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291771

Contacts
Contact: Denis ANGOULVANT, Dr 4 72 35 74 08 ext 33 denis.angoulvant@chu-lyon.fr

Locations
France
Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Denis ANGOULVANT, Dr    4 72 35 74 08 ext 33    denis.angoulvant@chu-lyon.fr   
Principal Investigator: Denis ANGOULVANT, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Denis ANGOULVANT, Dr Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01291771     History of Changes
Other Study ID Numbers: 2010.611
Study First Received: February 7, 2011
Last Updated: December 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 27, 2014