Coronary Artery Disease and Renal Failure Registry (CAD-REF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
BMBf (Federal Ministry of Education and Research)
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Amgen
AstraZeneca
Boehringer Ingelheim Pharma GmbH & Co. KG
Sanofi-Aventis Deutschland GmbH
Information provided by:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
ClinicalTrials.gov Identifier:
NCT00679419
First received: May 14, 2008
Last updated: November 1, 2012
Last verified: October 2012
  Purpose

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

Condition
Coronary Artery Disease
Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Artery Disease and Renal Failure Registry

Further study details as provided by Institut für Klinisch-Kardiovaskuläre Forschung GmbH:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: two years ]

Secondary Outcome Measures:
  • manner of death [ Time Frame: two years ]
    cardiac death; non-cardiac death; death of unknown cause


Other Outcome Measures:
  • Interventions [ Time Frame: two years ]
    Myocardial infarction or stroke; Renal failure or contrast medium induced nephropathy


Biospecimen Description:

Urine, whole blood, serum


Estimated Enrollment: 3352
Study Start Date: December 2007
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 0 (Controllgroup)
eGFR >= 90 ml/min/1.73m^2 and no proteinuria
Group 1
eGFR >= 90 ml/min/1.73m^2 and proteinuria
Group 2
eGFR 60 - 89 ml/min/1.73m^2
Group 3
eGFR 30 - 59 ml/min/1.73m^2
Group 4
eGFR 15 - 29 ml/min/1.73m^2
Group 5
eGFR < 15 ml/min/1.73m^2 or requiring dialysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679419

Locations
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
Klinikum Neuperlach
München, Germany
Klinik Augustium München
München, Germany
St. Franziskus-Hospital
Münster, Germany
Raphaelsklinik Münster
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, Germany
Sponsors and Collaborators
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
BMBf (Federal Ministry of Education and Research)
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Amgen
AstraZeneca
Boehringer Ingelheim Pharma GmbH & Co. KG
Sanofi-Aventis Deutschland GmbH
Investigators
Principal Investigator: Eva Brand, Prof. Dr. University Hospital of Muenster
Principal Investigator: Holger Reinecke, Prof. Dr. University Hospital of Muenster
Principal Investigator: Günter Breithardt, Prof. Dr. University Hospital of Muenster
Principal Investigator: Hermann Pavenstädt, Prof. Dr. University Hospital of Muenster
  More Information

No publications provided by Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00679419     History of Changes
Other Study ID Numbers: 1-071812
Study First Received: May 14, 2008
Last Updated: November 1, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014