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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comparator | Other | One group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years |
|
| coronary angiography group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular events | Major cardiovascular events
| Inclusion: 1 year - Follow up: 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests. | Inclusion: 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Past medical history of
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| Name | Affiliation | Role |
|---|---|---|
| Denis ANGOULVANT, Dr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon | Bron | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22344775 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D059347 | Cardio-Renal Syndrome |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |