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Coronary Artery DiseaseCAD-REFNCT00679419

Coronary Artery Disease and Renal Failure Registry

An observational study of Coronary Artery Disease and Renal Failure, run by Institut für Klinisch-Kardiovaskuläre Forschung GmbH at 32 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Renal Failure
How many people
3,352 participants
Where
32 sitesGermany
Study dates
Dec 2007to May 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Germany32 sites

  • Universitätsklinikum Aachen

    Aachen

  • Zentralklinik Bad Berka

    Bad Berka

  • Herz- und Gefäßklinik Bad Neustadt

    Bad Neustadt an der Saale

  • Schüchtermann-Klinik

    Bad Rothenfelde

  • Herzzentrum Brandenburg

    Brandenburg

  • St.-Vincenz-Hospital

    Coesfeld

  • Klinikum Lippe-Detmold

    Detmold

  • Herzzentrum Duisburg

    Duisburg

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf

  • Alfried Krupp Krankenhaus Essen

    Essen

  • Klinikum Garmisch-Partenkirchen

    Garmisch-Partenkirchen

  • Universitätsklinikum Halle/Saale

    Halle

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Evangelisches Krankenhaus Hamm

    Hamm

  • St. Marienhospital Hamm

    Hamm

  • Medizinische Hochschule Hannover

    Hanover

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn

  • Privatklinik Dr. Schindlbeck

    Herrsching am Ammersee

  • Herzzentrum Lahr

    Lahr

  • Kardiologische Praxis Dr. Schön

    Mühldorf

  • Klinik Augustium München

    München

  • Klinikum Neuperlach

    München

  • Raphaelsklinik Münster

    Münster

  • St. Franziskus-Hospital

    Münster

  • Universitätsklinikum Münster

    Münster

  • Lukaskrankenhaus Neuss

    Neuss

  • Euregioclinic Nordhorn

    Nordhorn

  • St. Vincenz-Krankenhaus

    Paderborn

  • Klinikum Pirna

    Pirna

  • Christliches Krankenhaus Quakenbrück e.V.

    Quakenbrück

  • Zentralklinikum Suhl

    Suhl

  • Josephs-Hospital Warendorf

    Warendorf

Other trials in Germany

About this study

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
Medical subject headings
Coronary Artery Disease, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00679419
Study groupRoleWhat they receive
Group 0 (Controllgroup)eGFR >= 90 ml/min/1.73m^2 and no proteinuria
Group 1eGFR >= 90 ml/min/1.73m^2 and proteinuria
Group 2eGFR 60 - 89 ml/min/1.73m^2
Group 3eGFR 30 - 59 ml/min/1.73m^2
Group 4eGFR 15 - 29 ml/min/1.73m^2
Group 5eGFR < 15 ml/min/1.73m^2 or requiring dialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all cause mortality

    Measured: two years

Secondary outcomes (1)

  1. manner of death

    cardiac death; non-cardiac death; death of unknown cause

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2011
  4. Study completionMay 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679419
Sponsor's protocol ID
1-071812
Acronym
CAD-REF
Status last verified
Oct 2012
First submitted
14 May 2008
Last updated
2 Nov 2012
Results posted
No

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.

    PubMed 34036426

  • 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.

    PubMed 28526542

  • 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.

    PubMed 24016493

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Renal Failure, run by Institut für Klinisch-Kardiovaskuläre Forschung GmbH at 32 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all cause mortality (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679419, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.

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