Chronic Kidney DiseaseKKTNCT01204645
Karolinska Cardiorenal Theme-centre and StockholmHeartbank
An observational study of Chronic Kidney Disease and Chronic Renal Failure, run by Danderyd Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease, Chronic Renal Failure, Acute Coronary Syndrome
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin <1.1 g/dL
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Danderyd University Hospital
Stockholm, 18288
Jonas Spaak, MD, PhD, +46 8 6557685, jonas.spaak@ds.se
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Acute Coronary Syndrome, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Composite
Combined endpoint of death, new cardiovascular event or dialysis.
Measured: 1 year
Secondary outcomes (2)
Renal function decline
Measured: 5 year
Vascular function
Vascular function assessed by arterial stiffness, microcirculation by Laser-Doppler
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2022 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Karolinska Institutet, Uppsala University, Lund University, Stockholm South General Hospital, Karolinska University Hospital
- Responsible party
- Principal investigator, Jonas Spaak, Danderyd Hospital
- Investigators
- Jonas Spaak, MD PhD, Study director, Karolinska Institutet and Danderyd University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204645
- Sponsor's protocol ID
- KKT
- Acronym
- KKT
- Status last verified
- Jun 2017
- First submitted
- 16 Sep 2010
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholmheartbank and Karolinska Cardiorenal Theme-centre, From Genome to Clinical Practice in Patients With Acute Coronary Syndrome and Impaired Kidney Function
- ClinicalTrials.gov ID
- NCT01204645
- Acronym / sponsor ID
- KKT / KKT
- Conditions
- Chronic Kidney Disease, Chronic Renal Failure, Acute Coronary Syndrome, Ischemic Heart Disease, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Region Stockholm, Karolinska Institutet, Uppsala University, Lund University, Stockholm South General Hospital, Karolinska University Hospital
- Study start
- May 2010
- Primary completion
- May 2022 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin <1.1 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite
Time frame: 1 year
Combined endpoint of death, new cardiovascular event or dialysis.
2 secondary outcomes
Renal function decline
Time frame: 5 year
Vascular function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Spaak, MD PhD study director
Karolinska Institutet and Danderyd University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Chronic Renal Failure, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Spaak, MD, PhD (+46 762014178, jonas.spaak@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.