Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease

Cardiovascular Diseases Clinical Trial

Official title:

Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease: A Prospective Study Combining Myocardial Perfusion Scintigraphy and Dobutamine Stress Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172064
• Other study ID #: 2008-564-f-S
• Status: Completed
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2019
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• GFR below 20 ml/min/1.73m²

Exclusion Criteria:

• children

• pregnant

Related Conditions & MeSH terms

• Cardiovascular Diseases
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Diagnostic Test:
• Myocardial perfusion scintigraphy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia	Number of patients with reversible perfusion defects in myocardial perfusion scintigraphy or wall motion abnormalities in stress echocardiography	january 2010 - june 2013