Karolinska Cardiorenal Theme-centre and StockholmHeartbank

Myocardial Infarction Clinical Trial

— KKT  

Official title:

Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204645
• Other study ID #: KKT
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2010
• Last updated: June 14, 2017
• Start date: May 2010
• Est. completion date: January 2024

Study information

• Verified date: June 2017
• Source: Danderyd Hospital
• Contact: Jonas Spaak, MD, PhD
• Phone: +46 762014178
• Email: jonas.spaak[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2024
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Kidney Disease
• Chronic Renal Failure
• Coronary Artery Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Myocardial Infarction
• Myocardial Ischemia
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Syndrome

Locations

Country	Name	City	State
Sweden	Danderyd University Hospital	Stockholm

Sponsors (7)

Lead Sponsor	Collaborator
Danderyd Hospital	Karolinska Institutet, Karolinska University Hospital, Lund University, Stockholm County Council, Sweden, Stockholm South General Hospital, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite	Combined endpoint of death, new cardiovascular event or dialysis.	1 year
Secondary	Renal function decline		5 year
Secondary	Vascular function	Vascular function assessed by arterial stiffness, microcirculation by Laser-Doppler	1 year