Karolinska Cardiorenal Theme-centre and StockholmHeartbank (KKT)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Chronic Kidney Disease; Acute Coronary Syndrome; Ischemic Heart Disease; Chronic Renal Failure

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jonas Spaak, MD, PhD; Phone Number: +46 762014178; Email: jonas.spaak@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Recruiting
    • Danderyd University Hospital
    • Contact: Jonas Spaak, MD, PhD; Phone Number: +46 8 6557685; Email: jonas.spaak@ds.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite	Combined endpoint of death, new cardiovascular event or dialysis.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function decline		5 year
Vascular function	Vascular function assessed by arterial stiffness, microcirculation by Laser-Doppler	1 year

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: Karolinska University Hospital; Karolinska Institutet; Lund University; Uppsala University; Region Stockholm; Stockholm South General Hospital
• Investigators: Study Director: Jonas Spaak, MD PhD, Karolinska Institutet and Danderyd University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Renal Insufficiency; Coronary Disease; Infarction; Myocardial Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Acute Coronary Syndrome
• Other Study ID Numbers: KKT