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93 active trials for Cardiovascular Disease

Preventing Atopic Dermatitis and ALLergies in Children

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

Start: December 2014

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

Start: July 2016

Intermittent Hypoxia Therapy in Cardiac Rehabilitation

This is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase 2 in-hospital cardiac rehabilitation program.

Start: February 2019

Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China

Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.

Start: September 2018

NOR-SYS: The Norwegian Stroke in the Young Study

NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol. Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease. Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years. Hypotheses: What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.

Start: September 2010

OCEAN Registry: Obesity and Clock for Elegant Aging Registry

This study aims to study the relationships between obesity, circadian rhythm, and aging. The investigators set up a prospective cohort registry for morbid obesity, obesity, and normal subjects with annual follow-up. The cohort aims to investigate the pathophysiological, molecular, genetic, and cellular aspects of the relationships between obesity, circadian deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and molecular signatures will be collected and investigated.

Start: July 2011

Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study

The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and patient related measures in STEMI patient who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main coronary arteries will be included in the trial and prospectively observed. The study will comprise 20 patients, who will undergo additional evaluation with optical coherence tomography (OCT) and near-infrared spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36 months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18 mm in length.

Start: June 2017

Monocentric Registry to Investigate the Role of Platelet Function, Platelet Genetics, Proteomics and Metabonomics in Heart Disease

Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.

Start: January 2012

Fernald Community Cohort -18 Year Observational Study

The Fernald Community Cohort consists of the 9782 persons who were enrolled in the Fernald Medical Monitoring Program (FMMP) (1990-2008). The initial comprehensive examination conducted as part of the Fernald Medical Monitoring Program (FMMP) began in the autumn of 1990. The FMMP provided 9,782 initial examinations and 42,775 re-examinations. An extensive computerized database and biospecimen repository was created to provide research resources for future studies. All questionnaire, examination and diagnostic procedure data collected from the FMMP were [coded by certified medical record coders,] double entered with verification into a SAS database on site of the examinations. Cryo-preserved blood and urine samples were collected at enrollment and at various intervals throughout follow-up. At the first examination three 1-ml aliquots of whole blood, plasma, serum, urine and urine with buffer were obtained from each participant (15 aliquots per person) for future analyses. Additional whole blood and serum was obtained in 1996-1997 and 2006-2008. Specimens have been stored in -80 degree freezers; over 160,000 biospecimens are in the archive. Since 1994, the FCC has had an established procedure for sharing data and biospecimens with qualified researchers. Both the policy and application forms can be found at www.eh.uc.edu/fmmp/research.

Start: September 1990

National Plaque Registry and Database

The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction. Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death. The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.

Start: September 2016

Cardiovascular Risk Factors, Lipid Metabolism and Oxidative Stress

Cardiovascular diseases belong to the major causes of mortality in western populations, and atherosclerosis is the lesion responsible for clinical events, such as acute myocardial infarction and stroke. Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors for atherosclerosis are being recognized. Some of them are responsible for the epidemiologically very serious metabolic syndrome, which accounts for development of hyperlipidemia, obesity, diabetes or arterial hypertension. Health providers in continental diet-based countries suggest to embracing Mediterranean diet in order to contribute in reducing cardiovascular mortality. However, countries in the Mediterranean area are experiencing a shift in dietary habit towards continental diet with potential harmful change in mortality rates. Oxidative stress, including free radical-driven reactions and antioxidant status are considered important mediators to be considered in the diet-mediated effect on health. Important metabolic functions are also mediated by certain fatty acids. A comprehensive study of oxidative stress, including free radical-driven products and protective antioxidants, and fatty acids metabolism has never been reported in healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative stress and fatty acids metabolism are rarely applied to epidemiological studies. The aim of the present grant project is therefore to assess in a large cross-sectional study the prevalence of oxidative stress markers, and fatty acids and to find any causal relation between these variables and metabolic syndrome. This population sample will be followed prospectively not only for time of the present grant project, but we would like to study metabolic variables with relation to the development of oxidative stress-mediated diseases, in particular those of cardiovascular system, on a longitudinal basis (prospective epidemiological study for at least 10 years). At same time we should be able to define the importance of individual markers of oxidative stress and fatty acids for early detection of these diseases.

Start: May 2009

Long-term Follow-up of the Helsinki Businessmen Study

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Start: January 1964

Markers of Coronary Artery Disease During Exercise Testing

The main purpose of this study is to examine whether changes in biomarkers during exercise are related to coronary artery disease demonstrated by coronary angiography or echocardiography.

Start: December 2011