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Karolinska Cardiorenal Theme-centre and StockholmHeartbank (KKT)

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ClinicalTrials.gov Identifier: NCT01204645
Recruitment Status : Recruiting
First Posted : September 17, 2010
Last Update Posted : June 15, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming recognized as one of the most serious disorders causing increased risk for cardiovascular disease and death. In patients with ischemic heart disease 26% have increased creatinine, which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function diminishes, and just slowing the rate of decline in renal function would have a tremendous impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome, though it is caused by a much more complex interplay between major pathogenetic pathways such as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism, coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system activation, endothelial dysfunction, lipid metabolism, fetal programming etc.

Karolinska Institutet recently merged basic and clinical researchers in all these fields, creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and provide improved care for the individual patient.

The investigators road to success:

  • Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients with ACS in Stockholm county - Stockholmheartbank.
  • This Theme Center include all teaching hospitals associated with Karolinska Institutet; Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset University Hospital. Together theses hospitals serve as emergency hospitals for 1.9 million people. The investigators are aiming at creating a biobank from all patients admitted for an acute coronary event (about 2.300/yr), which is a unique asset for molecular and genetic research as well as observational and intervention studies.
  • The investigators have access to the National registry with 100% coverage, that contains data on all patients admitted to Stockholms coronary care units since 1995.
  • To ensure translation in to clinical practice, most of the researchers are also MD:s, and several are clinically active.
  • The clinical network facilitates the development of novel therapies and translational research.
  • Steering groups for Education and a Clinical Practice implementation program.

Condition or disease
Chronic Kidney Disease Chronic Renal Failure Acute Coronary Syndrome Ischemic Heart Disease Myocardial Infarction

Study Design

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function
Study Start Date : May 2010
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : January 2024
Groups and Cohorts

Acute Coronary Syndrome (ACS)
Continuous inclusion at emergency hospitals of patients with acute coronary syndrome (according to ESC/AHA definitions)
Follow up
Patients included at 6 or 12 months follow-up visit after an acute coronary event.
Patients included when undergoing an coronary angiography for suspected or confirmed coronary heart disease

Outcome Measures

Primary Outcome Measures :
  1. Composite [ Time Frame: 1 year ]
    Combined endpoint of death, new cardiovascular event or dialysis.

Secondary Outcome Measures :
  1. Renal function decline [ Time Frame: 5 year ]
  2. Vascular function [ Time Frame: 1 year ]
    Vascular function assessed by arterial stiffness, microcirculation by Laser-Doppler

Biospecimen Retention:   Samples With DNA
Blood and plasma.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. All patients admitted to one of the four major emergency hospitals in Stockholm, for an acute coronary event.
  2. All patients admitted to one of the four major emergency hospitals in Stockholm, for an elective coronary angiography

Inclusion Criteria:

  • All patients admitted to one of the four major emergency hospitals in Stockholm, for an acute coronary event.
  • All patients admitted to one of the four major emergency hospitals in Stockholm, for an elective coronary angiography

Exclusion Criteria:

  • Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin <1.1 g/dL
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204645

Contact: Jonas Spaak, MD, PhD +46 762014178 jonas.spaak@ki.se

Danderyd University Hospital Recruiting
Stockholm, Sweden, 18288
Contact: Jonas Spaak, MD, PhD    +46 8 6557685    jonas.spaak@ds.se   
Sponsors and Collaborators
Danderyd Hospital
Stockholm County Council, Sweden
Karolinska Institutet
Uppsala University
Lund University
Stockholm South General Hospital
Karolinska University Hospital
Study Director: Jonas Spaak, MD PhD Karolinska Institutet and Danderyd University Hospital
More Information

Responsible Party: Jonas Spaak, MD PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01204645     History of Changes
Other Study ID Numbers: KKT
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Kidney Diseases
Heart Diseases
Myocardial Infarction
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Renal Insufficiency
Myocardial Ischemia
Coronary Artery Disease
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases