Myocardial Perfusion and Contractile Reserve in End-stage Renal Disease

NCT04172064 | Completed

• 1 other identifier: 2008-564-f-S
• Study Type: observational
• Target: 377
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End-Stage Renal Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Ischemia

  Number of patients with reversible perfusion defects in myocardial perfusion scintigraphy or wall motion abnormalities in stress echocardiography

  january 2010 - june 2013

Study Arms (1)

377patients evaluated by MPS and DSE

Diagnostic Test: Myocardial perfusion scintigraphy

Interventions

Myocardial perfusion scintigraphy DIAGNOSTIC_TEST

Also known as: Dobutamine stress echocardiography

377patients evaluated by MPS and DSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• GFR below 20 ml/min/1.73m²

You may not qualify if:

• children
• pregnant

Sponsors & Collaborators

• University Hospital Muenster: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases

Interventions

Myocardial Perfusion Imaging; Echocardiography, Stress

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Perfusion Imaging; Radionuclide Imaging; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Radioisotope; Echocardiography; Ultrasonography

Study Officials

• Michael Schäfers, Prof.

  Department of Nuclear Medicine, University Hospital Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share