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
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • Composite [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Combined endpoint of death, new cardiovascular event or dialysis.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Blood and plasma.


Estimated Enrollment: 10000
Study Start Date: May 2010
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/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.
Coronary
Patients included when undergoing an coronary angiography for suspected or confirmed coronary heart disease

  Eligibility

Genders Eligible for Study:   Both
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204645

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

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Jonas Spaak, MD PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01204645     History of Changes
Other Study ID Numbers: KKT
Study First Received: September 16, 2010
Last Updated: April 25, 2013
Health Authority: Sweden: The Swedish Data Inspection Board, informed and approved as of 2010-MAY-12

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Infarction
Kidney Diseases
Kidney Failure, Chronic
Myocardial Infarction
Renal Insufficiency
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014