Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease

NCT ID: NCT04172064

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 377 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

377patients evaluated by MPS and DSE

Myocardial perfusion scintigraphy

Intervention Type: DIAGNOSTIC_TEST

Interventions

Myocardial perfusion scintigraphy

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Dobutamine stress echocardiography

Eligibility Criteria

Inclusion Criteria

• GFR below 20 ml/min/1.73m²

Exclusion Criteria

• children
• pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Schäfers, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, University Hospital Münster

Other Identifiers

2008-564-f-S

Identifier Type: -

Identifier Source: org_study_id