Clinical trial NCT00679419: Coronary Artery Disease and Renal Failure Registry
Official title: Coronary Artery Disease and Renal Failure Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Renal Failure
Lead sponsor: Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Sponsor class: NETWORK
Collaborators: name: BMBf (Federal Ministry of Education and Research)
name: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
name: Amgen
name: AstraZeneca
name: Boehringer Ingelheim
name: Sanofi
First posted: 2008-05-16
Enrollment: 3352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed coronary artery disease were consecutively enrolled and classified into six groups according to their kidney function

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: all cause mortality
timeFrame: two years
Secondary outcomes:
measure: manner of death
timeFrame: two years
Other outcomes:
measure: Interventions
timeFrame: two years
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäßklinik Bad Neustadt
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Brandenburg
country: Germany
facility: Herzzentrum Brandenburg
city: Coesfeld
country: Germany
facility: St.-Vincenz-Hospital
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
city: Duisburg
country: Germany
facility: Herzzentrum Duisburg
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Essen
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
city: Halle/Saale
country: Germany
facility: Universitätsklinikum Halle/Saale
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm
city: Hamm
country: Germany
facility: St. Marienhospital Hamm
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Herrsching
country: Germany
facility: Privatklinik Dr. Schindlbeck
city: Lahr
country: Germany
facility: Herzzentrum Lahr
city: Mühldorf
country: Germany
facility: Kardiologische Praxis Dr. Schön
city: München
country: Germany
facility: Klinik Augustium München
city: München
country: Germany
facility: Klinikum Neuperlach
city: Münster
country: Germany
facility: Raphaelsklinik Münster
city: Münster
country: Germany
facility: St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss
city: Nordhorn
country: Germany
facility: Euregioclinic Nordhorn
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus
city: Pirna
country: Germany
facility: Klinikum Pirna
city: Quakenbrück
country: Germany
facility: Christliches Krankenhaus Quakenbrück e.V.
city: Suhl
country: Germany
facility: Zentralklinikum Suhl
city: Warendorf
country: Germany
facility: Josephs-Hospital Warendorf
Study officials:
affiliation: University Hospital of Muenster
name: Eva Brand, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Muenster
name: Holger Reinecke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Muenster
name: Günter Breithardt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Muenster
name: Hermann Pavenstädt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engelbertz C, Pinnschmidt HO, Freisinger E, Reinecke H, Schmitz B, Fobker M, Schmieder RE, Wegscheider K, Breithardt G, Pavenstadt H, Brand E. Sex-specific differences and long-term outcome of patients with coronary artery disease and chronic kidney disease: the Coronary Artery Disease and Renal Failure (CAD-REF) Registry. Clin Res Cardiol. 2021 Oct;110(10):1625-1636. doi: 10.1007/s00392-021-01864-5. Epub 2021 May 26.
citation: Engelbertz C, Reinecke H, Breithardt G, Schmieder RE, Fobker M, Fischer D, Schmitz B, Pinnschmidt HO, Wegscheider K, Pavenstadt H, Brand E. Two-year outcome and risk factors for mortality in patients with coronary artery disease and renal failure: The prospective, observational CAD-REF Registry. Int J Cardiol. 2017 Sep 15;243:65-72. doi: 10.1016/j.ijcard.2017.05.022. Epub 2017 May 7.
citation: Brand E, Pavenstadt H, Schmieder RE, Engelbertz C, Fobker M, Pinnschmidt HO, Wegscheider K, Breithardt G, Reinecke H. The Coronary Artery Disease and Renal Failure (CAD-REF) registry: trial design, methods, and aims. Am Heart J. 2013 Sep;166(3):449-56. doi: 10.1016/j.ahj.2013.06.010. Epub 2013 Jul 23.