End Stage Renal DiseaseMICROCARDNCT01291771
Myocardial Microvascular Disease in ESRD
A study testing Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire in people with End Stage Renal Disease and Myocardial Microvascular Disease, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Myocardial Microvascular Disease
- What is being tested?
- Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, 69677
About this study
Official title: Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease
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.
- Being tested
- Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire
- 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
- Medical subject headings
- Kidney Failure, Chronic, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wireProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| comparator | Other | One group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years Receives: Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire |
| 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 Receives: Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion: 1 year - Follow up: 2 years
Secondary outcomes (1)
Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.
Measured: Inclusion: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis ANGOULVANT, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291771
- Sponsor's protocol ID
- 2010.611
- Acronym
- MICROCARD
- Status last verified
- Jan 2015
- First submitted
- 7 Feb 2011
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22344775
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT01291771
- Acronym / sponsor ID
- MICROCARD / 2010.611
- 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
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparator | Other | Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wireOne group of patients with no myocardial ischemia on non invasive testing will be followed up for 2 years |
| coronary angiography group | Experimental | Procedure: Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wireOne group of patients with myocardial ischemia on non invasive testing will undergo coronary angiography and measure of FFR + CFR to detect myocardial microvascular disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wireThe 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. | Procedure or surgery | comparator, coronary angiography group |
Primary outcome
Major cardiovascular events
Time frame: 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
1 secondary outcome
Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.
Time frame: Inclusion: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Derived from this study: PubMed 22344775Bejan-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis ANGOULVANT, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire in people with End Stage Renal Disease and Myocardial Microvascular Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular events (time frame: Inclusion: 1 year - Follow up: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.