Clinical trial NCT01204645: Karolinska Cardiorenal Theme-centre and StockholmHeartbank
Official title: Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Chronic Renal Failure
Acute Coronary Syndrome
Ischemic Heart Disease
Myocardial Infarction
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Karolinska Institutet
name: Uppsala University
name: Lund University
name: Stockholm South General Hospital
name: Karolinska University Hospital
First posted: 2010-09-17
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Composite
timeFrame: 1 year
Secondary outcomes:
measure: Renal function decline
timeFrame: 5 year
measure: Vascular function
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
Study officials:
affiliation: Karolinska Institutet and Danderyd University Hospital
name: Jonas Spaak, MD PhD
role: STUDY_DIRECTOR
References: