Karolinska Cardiorenal Theme-centre and StockholmHeartbank (KKT)

This study is currently recruiting participants.
Verified April 2013 by Danderyd Hospital
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Karolinska Institutet
Uppsala University
Lund University
Stockholm South General Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01204645
First received: September 16, 2010
Last updated: April 25, 2013
Last verified: April 2013

September 16, 2010
April 25, 2013
May 2010
May 2015   (final data collection date for primary outcome measure)
Composite [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Combined endpoint of death, new cardiovascular event or dialysis.
Same as current
Complete list of historical versions of study NCT01204645 on ClinicalTrials.gov Archive Site
  • Renal function decline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Vascular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Vascular function assessed by arterial stiffness, microcirculation by Laser-Doppler
Same as current
Not Provided
Not Provided
 
Karolinska Cardiorenal Theme-centre and StockholmHeartbank
Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and plasma.

Probability Sample
  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
  • Chronic Kidney Disease
  • Chronic Renal Failure
  • Acute Coronary Syndrome
  • Ischemic Heart Disease
  • Myocardial Infarction
Not Provided
  • 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.
  • Coronary
    Patients included when undergoing an coronary angiography for suspected or confirmed coronary heart disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
January 2021
May 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Jonas Spaak, MD, PhD +46 762014178 jonas.spaak@ki.se
Sweden
 
NCT01204645
KKT
Yes
Jonas Spaak, Danderyd Hospital
Danderyd Hospital
  • Stockholm County Council, Sweden
  • Karolinska Institutet
  • Uppsala University
  • Lund University
  • Stockholm South General Hospital
  • Karolinska University Hospital
Not Provided
Danderyd Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP