Karolinska Cardiorenal Theme-centre and StockholmHeartbank

NCT01204645 | Unknown DMC

• 1 other identifier: KKT
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Composite

  Combined endpoint of death, new cardiovascular event or dialysis.

  1 year

Secondary Outcomes (2)

• Renal function decline

  5 year

• Vascular function

  1 year

Study Arms (3)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin \<1.1 g/dL

Sponsors & Collaborators

• Danderyd Hospital: lead
• Region Stockholm: collaborator
• Karolinska Institutet: collaborator
• Uppsala University: collaborator
• Lund University: collaborator
• Stockholm South General Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Danderyd University Hospital

Stockholm, 18288, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and plasma.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Acute Coronary Syndrome; Myocardial Ischemia; Myocardial Infarction

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Jonas Spaak, MD PhD

  Karolinska Institutet and Danderyd University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jonas Spaak, MD, PhD

CONTACT

+46 762014178; jonas.spaak@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2022
• Study Completion: January 1, 2024
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

SE (1)