Coronary Artery Disease and Renal Failure Registry

Coronary Artery Disease Clinical Trial

— CAD-REF  

Official title:

Coronary Artery Disease and Renal Failure Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00679419
• Other study ID #: 1-071812
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2008
• Last updated: November 1, 2012
• Start date: December 2007
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: Institut für Klinisch-Kardiovaskuläre Forschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3352
• Est. completion date: May 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz- und Gefäßklinik Bad Neustadt	Bad Neustadt
Germany	Schüchtermann-Klinik	Bad Rothenfelde
Germany	Herzzentrum Brandenburg	Brandenburg
Germany	St.-Vincenz-Hospital	Coesfeld
Germany	Klinikum Lippe-Detmold	Detmold
Germany	Herzzentrum Duisburg	Duisburg
Germany	Evangelisches Krankenhaus Düsseldorf	Düsseldorf
Germany	Alfried Krupp Krankenhaus Essen	Essen
Germany	Klinikum Garmisch-Partenkirchen	Garmisch-Partenkirchen
Germany	Universitätsklinikum Halle/Saale	Halle/Saale
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Evangelisches Krankenhaus Hamm	Hamm
Germany	St. Marienhospital Hamm	Hamm
Germany	Medizinische Hochschule Hannover	Hannover
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn
Germany	Privatklinik Dr. Schindlbeck	Herrsching
Germany	Herzzentrum Lahr	Lahr
Germany	Kardiologische Praxis Dr. Schön	Mühldorf
Germany	Klinik Augustium München	München
Germany	Klinikum Neuperlach	München
Germany	Raphaelsklinik Münster	Münster
Germany	St. Franziskus-Hospital	Münster
Germany	Universitätsklinikum Münster	Münster
Germany	Lukaskrankenhaus Neuss	Neuss
Germany	Euregioclinic Nordhorn	Nordhorn
Germany	St. Vincenz-Krankenhaus	Paderborn
Germany	Klinikum Pirna	Pirna
Germany	Christliches Krankenhaus Quakenbrück e.V.	Quakenbrück
Germany	Zentralklinikum Suhl	Suhl
Germany	Josephs-Hospital Warendorf	Warendorf

Sponsors (7)

Lead Sponsor	Collaborator
Institut für Klinisch-Kardiovaskuläre Forschung GmbH	Amgen, AstraZeneca, BMBf (Federal Ministry of Education and Research), Boehringer Ingelheim, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Sanofi-Aventis Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interventions	Myocardial infarction or stroke; Renal failure or contrast medium induced nephropathy	two years
Primary	all cause mortality		two years
Secondary	manner of death	cardiac death; non-cardiac death; death of unknown cause	two years