Karolinska Cardiorenal Theme-centre and StockholmHeartbank (KKT)
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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 |
|---|
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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 |
- Composite [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Combined endpoint of death, new cardiovascular event or dialysis.
- 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 |
- 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
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| Contact: Jonas Spaak, MD, PhD | +46 762014178 | jonas.spaak@ki.se |
| Sweden | |
| Danderyd University Hospital | Recruiting |
| Stockholm, Sweden, 18288 | |
| Contact: Jonas Spaak, MD, PhD +46 8 6557685 jonas.spaak@ds.se | |
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 May 19, 2013