End-Stage Renal DiseaseNCT04172064
Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease
An observational study of End-Stage Renal Disease and Cardiovascular Diseases, run by University Hospital Muenster.
Trial summary
The investigators prospectively recruited a total of 377 ESRD patients evaluated for kidney transplantation between January 2010 and July 2013 in our centre. Criteria for participation were a GFR below 20 ml/min/1.73m² or the need for haemodialysis and an age ≥18 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Cardiovascular Diseases
- What is being tested?
- Myocardial perfusion scintigraphy
- How many people
- 377 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2013
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: 377 ESRD patients evaluated for kidney transplantation between January 2010 and July 2013 in our centre. Criteria for participation were a GFR below 20 ml/min/1.73m² or the need for haemodialysis and an age ≥18 years. 323 patients were on regular dialysis, the remaining 54 patients were being prepared for impending dialysis. Patients with known ischemic heart disease were excluded from the study.
Who may be able to join
- GFR below 20 ml/min/1.73m²
Who cannot join
- children
- pregnant
About this study
Official title: Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease: A Prospective Study Combining Myocardial Perfusion Scintigraphy and Dobutamine Stress Echocardiography
The investigators prospectively recruited a total of 377 ESRD patients evaluated for kidney transplantation between January 2010 and July 2013 in our centre. Criteria for participation were a GFR below 20 ml/min/1.73m² or the need for haemodialysis and an age ≥18 years. 323 patients were on regular dialysis, the remaining 54 patients were being prepared for impending dialysis. Patients with known ischemic heart disease were excluded from the study. All patients underwent a systematic analysis of cardiovascular risk factors based on structured interviews with a physician, health records, blood lipid levels, and routine MPS at rest and under stress. In addition, 230 ESRD patients (61%) received standardized DSE. Patients with signs of ischemia in MPS and/or DSE were evaluated for coronary angiography on clinical grounds.
Read the detailed description
End-stage renal disease (ESRD) is a critical condition and bears a high risk of cardiovascular events. However, clinical algorithms to identify patients with coronary vasculopathies are still not defined and standardized. Non-invasive imaging by myocardial perfusion scintigraphy (MPS) or dobutamine stress echocardiography (DSE) might be used in such patients, however, it is unclear if these provide complementary or identical information and how this correlates to coronary angiography. A direct comparison of these imaging approaches, excellently validated in coronary artery disease, has not yet been described in well-defined and large groups of ESRD patients.
The investigators therefore initiated a large prospective trial with 377 highly-selected and well-characterized end-stage renal disease patients without known coronary artery disease comparing the performance of standardized MPS and DSE. For the first time we here describe a significantly large proportion of ESRD patients with contradictory findings in MPS and DSE and its correlation to invasive coronary angiography hinting to complementary rather than identical information between both modalities. This is an excellent basis of future studies comparing the prognostic value of MPS versus DSE versus a combined MPS/DSE approach.
- Conditions
- End-Stage Renal Disease, Cardiovascular Diseases
- Being tested
- Myocardial perfusion scintigraphy
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial perfusion scintigraphyDiagnostic test
Also called Dobutamine stress echocardiography
| Study group | Role | What they receive |
|---|---|---|
| 377patients evaluated by MPS and DSE | Not described Receives: Diagnostic Test: Myocardial perfusion scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia
Number of patients with reversible perfusion defects in myocardial perfusion scintigraphy or wall motion abnormalities in stress echocardiography
Measured: january 2010 - june 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 377 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Schäfers, Prof., Principal investigator, Department of Nuclear Medicine, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172064
- Sponsor's protocol ID
- 2008-564-f-S
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease: A Prospective Study Combining Myocardial Perfusion Scintigraphy and Dobutamine Stress Echocardiography
- ClinicalTrials.gov ID
- NCT04172064
- Acronym / sponsor ID
- 2008-564-f-S
- Conditions
- End-Stage Renal Disease, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Nov 2019 (actual)
- 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.
The investigators prospectively recruited a total of 377 ESRD patients evaluated for kidney transplantation between January 2010 and July 2013 in our centre. Criteria for participation were a GFR below 20 ml/min/1.73m² or the need for haemodialysis and an age ≥18 years. 323 patients were on regular dialysis, the remaining 54 patients were being prepared for impending dialysis. Patients with known ischemic heart disease were excluded from the study. All patients underwent a systematic analysis of cardiovascular risk factors based on structured interviews with a physician, health records, blood lipid levels, and routine MPS at rest and under stress. In addition, 230 ESRD patients (61%) received standardized DSE. Patients with signs of ischemia in MPS and/or DSE were evaluated for coronary angiography on clinical grounds.
Detailed description
End-stage renal disease (ESRD) is a critical condition and bears a high risk of cardiovascular events. However, clinical algorithms to identify patients with coronary vasculopathies are still not defined and standardized. Non-invasive imaging by myocardial perfusion scintigraphy (MPS) or dobutamine stress echocardiography (DSE) might be used in such patients, however, it is unclear if these provide complementary or identical information and how this correlates to coronary angiography. A direct comparison of these imaging approaches, excellently validated in coronary artery disease, has not yet been described in well-defined and large groups of ESRD patients.
The investigators therefore initiated a large prospective trial with 377 highly-selected and well-characterized end-stage renal disease patients without known coronary artery disease comparing the performance of standardized MPS and DSE. For the first time we here describe a significantly large proportion of ESRD patients with contradictory findings in MPS and DSE and its correlation to invasive coronary angiography hinting to complementary rather than identical information between both modalities. This is an excellent basis of future studies comparing the prognostic value of MPS versus DSE versus a combined MPS/DSE approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 377patients evaluated by MPS and DSE | – | Diagnostic Test: Myocardial perfusion scintigraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 377 ESRD patients evaluated for kidney transplantation between January 2010 and July 2013 in our centre. Criteria for participation were a GFR below 20 ml/min/1.73m² or the need for haemodialysis and an age ≥18 years. 323 patients were on regular dialysis, the remaining 54 patients were being prepared for impending dialysis. Patients with known ischemic heart disease were excluded from the study.
Key inclusion criteria (1 listed)
- GFR below 20 ml/min/1.73m²
Key exclusion criteria (2 listed)
- children
- pregnant
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 |
|---|---|---|
| Myocardial perfusion scintigraphyAlso: Dobutamine stress echocardiography | Diagnostic test | 377patients evaluated by MPS and DSE |
Primary outcome
Ischemia
Time frame: january 2010 - june 2013
Number of patients with reversible perfusion defects in myocardial perfusion scintigraphy or wall motion abnormalities in stress echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Michael Schäfers, Prof. principal investigator
Department of Nuclear Medicine, University Hospital Münster
Questions about this trial
What is this clinical trial studying?
An observational study of End-Stage Renal Disease and Cardiovascular Diseases, run by University Hospital Muenster.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ischemia (time frame: january 2010 - june 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2019.