NCT00679419

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

32 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3.4 years

First QC Date

May 14, 2008

Last Update Submit

November 1, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    two years

Secondary Outcomes (1)

  • manner of death

    two years

Other Outcomes (1)

  • Interventions

    two years

Study Arms (6)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosed coronary artery disease were consecutively enrolled and classified into six groups according to their kidney function

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Universitätsklinikum Aachen

Aachen, Germany

Location

Zentralklinik Bad Berka

Bad Berka, Germany

Location

Herz- und Gefäßklinik Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Schüchtermann-Klinik

Bad Rothenfelde, Germany

Location

Herzzentrum Brandenburg

Brandenburg, Germany

Location

St.-Vincenz-Hospital

Coesfeld, Germany

Location

Klinikum Lippe-Detmold

Detmold, Germany

Location

Herzzentrum Duisburg

Duisburg, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Alfried Krupp Krankenhaus Essen

Essen, Germany

Location

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany

Location

Universitätsklinikum Halle/Saale

Halle, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Evangelisches Krankenhaus Hamm

Hamm, Germany

Location

St. Marienhospital Hamm

Hamm, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Location

Privatklinik Dr. Schindlbeck

Herrsching am Ammersee, Germany

Location

Herzzentrum Lahr

Lahr, Germany

Location

Kardiologische Praxis Dr. Schön

Mühldorf, Germany

Location

Klinik Augustium München

München, Germany

Location

Klinikum Neuperlach

München, Germany

Location

Raphaelsklinik Münster

Münster, Germany

Location

St. Franziskus-Hospital

Münster, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Lukaskrankenhaus Neuss

Neuss, Germany

Location

Euregioclinic Nordhorn

Nordhorn, Germany

Location

St. Vincenz-Krankenhaus

Paderborn, Germany

Location

Klinikum Pirna

Pirna, Germany

Location

Christliches Krankenhaus Quakenbrück e.V.

Quakenbrück, Germany

Location

Zentralklinikum Suhl

Suhl, Germany

Location

Josephs-Hospital Warendorf

Warendorf, Germany

Location

Related Publications (3)

  • 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.

Related Links

Biospecimen

Urine, whole blood, serum

MeSH Terms

Conditions

Coronary Artery DiseaseRenal Insufficiency

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

December 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2013

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations