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Role of lipoproteins in cardiovascular disease - the LipidCardio study

Organizational Data

DRKS-ID:
DRKS00020915
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2020-02-27
Last update in DRKS:
2020-02-27
Registration type:
Retrospective

Acronym/abbreviation of the study

LipidCardio

URL of the study

No Entry

Brief summary in lay language

The LipidCardio study is a cooperation project between the Lipid Outpatient Clinic at the Interdisciplinary Metabolism Centre at the Virchow Clinic Campus and the Clinic for Cardiology at the Benjamin Franklin Campus (both Charité - Universitätsmedizin Berlin). The LipidCardio study is an observational study focusing on the prevalence and correlates of lipoprotein(a) [Lp(a)], in patients undergoing cardiac catheterization for angiographic assessment of coronary artery disease (CHD). One aim of the study is a better understanding of the role of Lp(a) in cardiovascular disease and the development of diabetes mellitus type II. In a first step, the focus is on a comprehensive phenotyping and exploration of cross-sectional associations. Routine laboratory data will be collected and a comprehensive lipid profile including Lp(a) will be drawn. In addition, comprehensive clinical data will be collected. In addition, DNA is collected from all participants for molecular genetic analysis. Additional blood samples are stored in a central biobank (ZeBanC) and offer the option for further measurements later.

Brief summary in scientific language

The LipidCardio study is a cooperation project between the Lipid Outpatient Clinic at the Interdisciplinary Metabolism Centre at the Virchow Clinic Campus and the Clinic for Cardiology at the Benjamin Franklin Campus (both Charité - Universitätsmedizin Berlin). The LipidCardio study is an observational study focusing on the prevalence and correlates of lipoprotein(a) [Lp(a)], in patients undergoing cardiac catheterization for angiographic assessment of coronary artery disease (CHD). One aim of the study is a better understanding of the role of Lp(a) in cardiovascular disease and the development of diabetes mellitus type II. In a first step, the focus is on a comprehensive phenotyping and exploration of cross-sectional associations. Routine laboratory data will be collected and a comprehensive lipid profile including Lp(a) will be drawn. In addition, comprehensive clinical data will be collected. In addition, DNA is collected from all participants for molecular genetic analysis. Additional blood samples are stored in a central biobank (ZeBanC) and offer the option for further measurements later.

Health condition or problem studied

ICD10:
I00-I99 - Diseases of the circulatory system
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients undergoing cardiac catheterization were enrolled. Along with the results of this diagnostic procedure, baseline data from the patients records and results from an interview were included in the study database. Additionally, the following parameters were collected: laboratory parameters, patients and family history, cognitive screening (Mini Mental State Examination), puls wave velocity, hand gripstrength. Follow-up interviews are planned after 3 and 6 years.

Endpoints

Primary outcome:
• objective health: cardiovascular diseases, results from coronary angiography, metabolic diseases, musculoskeletal diseases (anamnesis, laboratory Tests of blood) • functional parameters, physical activity and fitness (z.B. gripstrength, RAPA-rapid assessment of physical activity questionnaire) • cognitive test (MMSE)
Secondary outcome:
• medication/anamnesis • life style (Questionnaire) • anthropometic measurements • blood pressure and pulse wave velocity • den Seattle-Angina-Questionnaire • Biobanking: Serum, Plasma, DNA

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Charité - Universitätsmedizin Berlin Berlin

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-10-02
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1000
Final Sample Size:
1005

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients undergoing cardiac catheterisation at the Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin.

Exclusion Criteria

Troponin-positive acute coronary syndromes (ACS)

Addresses

Primary Sponsor

Charité - Universitätsmedizin BerlinMedizinische Klinik für Kardiologie
Prof. Ulf Landmesser
Hindenburgdamm 30
12200 Berlin
Germany
Telephone:
+49 30 450 513 702
Fax:
+49 30 450 513 999
Contact per E-Mail
URL:
https://kardio-cbf.charite.de/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité Campus Virchow-Klinikum
Prof. Dr. Ilja Demuth
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 450 569 143
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de

Contact for Public Queries

Charité Campus Virchow-Klinikum
Prof. Dr. Ilja Demuth
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 450 569 143
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de

Principal Investigator

Charité Campus Virchow-Klinikum
Prof. Dr. Ilja Demuth
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 450 569 143
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Charité Campus Charité Mitte
Charitéplatz 1
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-04-26
Ethics committee number:
EA1/135/16
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-06-27

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Groups interested in data or biobanked samples/DNA from LipidCardio should contact the study coordinating PI Ilja Demuth at ilja.demuth@charite.de for the data-sharing application form. Each application will be reviewed by the LipidCardio PIs and the decision communicated to the applicants usually within 6 weeks of submission.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Cohort profile - LipidCardio Study
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry