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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Renal Failure

• Study Type: Observational
• Enrollment (Anticipated): 3352

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
manner of death	cardiac death; non-cardiac death; death of unknown cause	two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interventions	Myocardial infarction or stroke; Renal failure or contrast medium induced nephropathy	two years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• CAD-REF Homepage

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): November 2, 2012
• Last Update Submitted That Met QC Criteria: November 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Renal Insufficiency
• Other Study ID Numbers: 1-071812