Further Studies/Projects

  • AtheroPrevalence-Studie
  • PREVENT-it-Pilotstudie
  • Gutenberg-HerzINFARKT-Studie
  • INEF (Impact of niacin on endothelial function)
  • TEAMSTA PROTECT I

AtheroPrevalence-Study

Study Management:

  • Univ.-Prof. Dr. med. Philipp Wild, M. Sc.
  • Univ.-Prof. Dr. med. Stefan Blankenberg


Brief summary:

Atherosclerotic vascular diseases in general and coronary heart disease in particular are the leading causes of premature death, loss of functional capacity and reduction of quality of life in Europe and in Germany. Even though they are largely preventable diseases, their incidence in Germany is higher than in many other Western European countries. Simply with consistent implementation of the recommendations for prevention on the lifestyle aspects of smoking, diet, weight and physical activity, about half of the atherosclerotic diseases could be prevented already.

However, when people are asked about their risk of developing the disease, it is often found that, on average, they estimate their risk to be lower than that of their peers. The phenomenon of people averagely describing their own risk as below average has meanwhile been shown for different health problems, so that the finding can be rated as very robust. In the area of cardiovascular disease, 14 out of a total of 15 studies show that the respondents' own risk of suffering a heart attack was estimated to be lower than that of other people.

The present study in young adults is designed to assess the prevalence of subclinical markers such as endothelial dysfunction, intermediate biochemical markers and genetic variations of cardiovascular candidate genes. By comparing these parameters, they can be examined for correlations. Comparison to future cohorts and further epidemiological studies will reveal whether markers of subclinical atherosclerosis provide additional information for individual cardiovascular risk stratification to those risk factors that are generally termed "classical" or "traditional."

The scheduled examinations will be conducted at the GHS study center on a single date.

Study participants (students) will receive a report summarizing their individual results upon completion of the study. In case of findings that require therapy, the study participant and, if desired, the family physician will be informed. Additionally, the participants are given the opportunity to inform themselves about the significance of their individual results in a final lecture at the end of the study and thus raise their awareness for primary prevention of arteriosclerotic diseases.

The aim of identifying the genetic determinants of multifactorial diseases, such as coronary heart disease or diabetes, is to identify genetic factors for the development of these complex genetic diseases in order to lay the foundation for individualized medicine with individualized risk assessment.

In the present study, a DNA sample will be obtained from each participant for genetic testing. The data obtained shall allow for conclusions on the functional significance of the respective genetic variability by comparison to measurements of intermediate biochemical traits as well as subclinical parameters of atherosclerotic disease. Furthermore, the data from this comparatively young cohort are supposed to allow for further scientific investigations in order to understand atherosclerosis by comparison to the other cohorts with specific characteristics.
Study type Monocentric cross-sectional study
Official title Prevalence of subclinical atherosclerosis and cardiovascular risk factors in students of Johannes Gutenberg University
Study participants 300 students of Johannes Gutenberg University Mainz, aged 20 - 30 years
Duration of the study One-time examination with a duration of approx. 3.5 hours
Status Completed

PREVENT-it-Pilot Study

Prevalence of subclinical atherosclerosis and cardiovascular risk factors in the Rhine-Main region
  • Study Management:
    • Univ.-Prof. Dr. med. Philipp Wild, M. Sc.
    • Univ.-Prof. Dr. med. Stefan Blankenberg
Subject Volunteers; Students
Design Beo Monocentric cross-sectional study as feasibility study for prospective cohort study GHS
Study participants Residents of the Rhine-Main region aged 20 to 80 years who volunteered to participate in the study and students of the Johannes Gutenberg University Mainz aged 20 to 30 years
Status 860 study participants
Objectives

The aim of this study is to evaluate risk factors for cardiovascular diseases and the importance of screening for early detection. For this purpose, known and new risk factors will be investigated. With the results of the study, we hope to improve prediction of the risk of cardiovascular disease for individuals. By identifying risk constellations at an early stage, preventive measures can be taken to prevent heart attacks and strokes.

Cancer is the second most common cause of death and disease in Germany after cardiovascular disease. The development of cancer is usually not based on a single cause, but on many different factors. Not all of these factors are known yet. With this study, we want to gain new knowledge about which factors increase the risk of cancer.
Study procedure  
Summary

Cardiovascular diseases are the most common cause of death and disease in Western industrialized countries. The incidence of heart disease has increased dramatically in recent years. Future projections for the United States showed that the incidence of coronary heart disease and hypertension will double during this century. In particular, the incidence of cardiovascular risk factors is increasing. In industrialized countries, more than one third of the population has high cholesterol. Other risk factors for cardiovascular disease include smoking, diabetes, hereditary stress, obesity and physical inactivity.

The aim of this study is to evaluate the occurence and severity of cardiovascular disease risk factors and the importance of screening for early detection of atherosclerotic changes. For this purpose, known and new risk factors will be investigated. The results of the study should help to better predict the risk of cardiovascular disease on an individual basis. By identifying risk constellations at an early stage, preventive measures can be taken to prevent heart attacks and strokes.

In addition to further research into atherosclerosis, the experience gained from this study will also form the basis for conducting a large population-based study. In the Gutenberg Health Study, 15,000 Rhineland-Palatinate patients aged 35-74 years will be examined for the presence of atherosclerosis and various risk factors for cardiovascular disease.

Gutenberg-HerzINFARKT-Study

Study Management: Univ.-Prof. Dr. med. Stefan Blankenberg

Brief summary:
Study type Multicentric, epidemiologic, prospective cohort study
Official title Die Gutenberg HerzINFARKT-Studie
Study participants Approximately 300 patients between the ages of 18 - 45 years who were hospitalized with myocardial infarction
Duration of the study 4.5 years plus minimum of 3 months
Status  

INEF (Impact of niacin on endothelial function)

  • Study Management: Univ.-Prof. Dr. med. Philipp Wild,

                                    Dr. med. Ascan Warnholtz   

Brief summary: More than one third of the population in industrialized countries has abnormal cholesterol levels. An increase in cholesterol levels leads to deposits in fatty tissue and in arteries. The higher this concentration, the greater the risk that the cholesterol will be deposited as plaque: this leads to increasing calcification of the vascular system and to a deterioration of vascular function; constriction of blood vessels and weakening of arterial walls occur. This can lead to coronary heart disease and, if it progresses further, to heart attacks or strokes. Therefore, therapy of lipid metabolism disorder and improvement of vascular function are important goals that are addressed in the drug treatment of atherosclerosis or coronary heart disease. The active ingredient investigated in the clinical trial - niacin - is a derivative of nicotinic acid. According to the available scientific data, nicotinic acid seems to be able to halt or even somewhat reverse the progression of atherosclerosis by improving blood lipid levels in the body and, in particular, increasing HDL cholesterol. An early marker of vascular function improvement is the so-called endothelial function. The endothelium is the inner lining of the vessel. Ultrasound can be used to measure endothelial function. The clinical trial is now intended to determine whether the improvement in cholesterol levels resulting from the administration of niacin in addition to standard drug treatment has a protective effect as well as an improvement of coronary heart disease. For this purpose, vascular function is determined before and after therapy with niacin. The second aim is to investigate the effects of therapy with niacin on the composition of blood lipids with their subunits as well as the changes of cardiovascular biomarkers in blood and urine during therapy. Cardiovascular biomarkers are characteristics measured in e.g. blood or urine that can indicate something: e.g. the risk of disease, degree of expression or progression of the disease. Participation in the clinical trial lasts 12 weeks ± 1 week for each patient. At the beginning of participation in this clinical trial, an enrollment examination is performed. If the criteria for study participation are met, the study drug is given to the patient. After approximately 2 weeks (plus/minus 5 days), a telephone interview regarding tolerability of the drug will take place. After another 10 weeks (plus/minus 1 week), the final examination is carried out.
Study type Clinical study in phase IIIb
Study design Prospective, randomized, double-blind, placebo-controlled, monocenter study
Official title Impact of 12 weeks of oral niacin therapy on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease.
Study participants 107 patients (f/m) between 35 and 80 years of age
Duration of the study 12 weeks
Status Published

TEAMSTA PROTECT I

  • Study Management: Univ.-Prof. Dr. med. Philipp Wild, M. Sc.,
                                   Univ.-Prof. Dr. med. Stefan Blankenberg
Brief summary

Insight into a unique "high blood pressure study"

Since August 2010, a study on hypertension has been conducted at the IInd Medical Clinic: TEAMSTA PROTECT I. It was initiated by Prof. Blankenberg and Prof. Münzel. Prof. Wild has taken over the function of principal investigator since April. The study compares a possible add-on effect of two antihypertensive drug combinations (telmisartan and amlodipine vs. olmesartan and hydrochlorothiazide) on endothelial function. Endothelial dysfunction is considered a predictor of cardiovascular events in the current concept of atherosclerosis.

The conduct of this study is possible, among other things, thanks to the support of Boehringer Ingelheim Pharma GmbH & Co. KG as well as the interdisciplinary cooperation of the IInd Medical Clinic, the study pharmacy of the University Medicine and the IZKS Mainz, true to its motto "Conducting successful clinical studies together".

In the context of this study, many logistical demands arise for the staff: The team around Dr. Jagodzinski, consisting of two medical assistants and at times 15 research assistants, meets these challenges. Every day, up to 8 patients were enrolled in the study in order to be able to include all of the 576 patients within only 6 months.

Before and after completion of the 26-week treatment phase, patients undergo a comprehensive check-up, in collaboration with the Gutenberg Heart Study. The focus is the primary endpoint of endothelial function after 26 weeks of treatment. This will be measured by FMD (flow-mediated dilation). Since this measurement is only performed at a few sites, a monocentric design was chosen.

Also involved in the conduct of the study is the study pharmacy, which performs the encapsulation, blinding and delivery of the study medication.

To assist in medication management, the function of the software "RandomiXer" developed by IZKS Mainz, a program for stratified online randomization, i.e. random assignment of patients to one of the two treatment arms, was expanded. "RandomiXer" provides an up-to-date overview of the number of patients treated and now also displays the exact inventory of study medication at the center. The pharmacy staff is automatically informed when the quantity of assignable medication on site at the study center falls below a certain level and new medication must therefore be delivered.

The IZKS Mainz is responsible for data management, biometrics and monitoring of the study and supports the study management in regulatory work.
Study type  
Design Randomized, controlled, monocentric double-blind study
Official title A TELmisartan and AMlodipine STudy to Assess the cardiovascular PROTECTive effects as measured by endothelial dysfunction in hypertensive at risk patients beyond blood pressure
Study participants 567 patients (f/m) with minimum age 35 years
Duration of the study 6 months inclusion phase
26 weeks treatment phase
Status  
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