Overview

This trial is active, not recruiting.

Conditions coronary artery disease, renal failure
Sponsor Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Collaborator BMBf (Federal Ministry of Education and Research)
Start date December 2007
End date May 2011
Trial size 3352 participants
Trial identifier NCT00679419, 1-071812

Summary

It is the aim of the multi-centric and prospective registry to analyze in patients with CAD the impact of different grades of renal failure on the outcome and course of the patients and to correlate these with clinical variables.

In particular, the registry has the following objectives:

- prospective consecutive assessment of all patients with coronary artery disease and renal failure in the participating hospitals of the registry

- evaluation of the outcome and course of patients with regard to their different stages of renal failure at baseline

- analysis of the impact of different therapeutic strategies on acute and long-term outcomes

- identification of clinical risk factors, novel biomarkers and genetic markers for an unfavorable long-term outcome

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
eGFR >= 90 ml/min/1.73m^2 and no proteinuria
eGFR >= 90 ml/min/1.73m^2 and proteinuria
eGFR 60 - 89 ml/min/1.73m^2
eGFR 30 - 59 ml/min/1.73m^2
eGFR 15 - 29 ml/min/1.73m^2
eGFR < 15 ml/min/1.73m^2 or requiring dialysis

Primary Outcomes

Measure
all cause mortality
time frame: two years

Secondary Outcomes

Measure
manner of death
time frame: two years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Women and men >= 18 years of age - Patients with actually performed interventional coronary angiography and there a documented coronary heart disease, defined as at least one documented stenosis >= 50 % in at least one main coronary vessel (Main steam; RCX; RIVA; RCA) - European/Caucasian descent (European/Caucasian parents and grandparents) - Availability of an urine, serum- and EDTA blood sample of the patient - Documented consent of patients for handling of personal medical data, including a genetic analysis Exclusion Criteria: - Patients who have been already recruited into this registry - Patients with organ transplantations, apart from kidney transplantations - Immunosuppressive therapy, apart from immunosuppressive therapy after kidney transplantation - Patients with polycystic renal disease - Pregnant and breastfeeding patients - Known malignant tumor

Additional Information

Official title Coronary Artery Disease and Renal Failure Registry
Principal investigator Eva Brand, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Institut für Klinisch-Kardiovaskuläre Forschung GmbH.