Prospective cohort study for the evaluation of diagnostic and therapeutic strategies of acute thoracic pain in the Chest Pain Unit (ProsPECTUS)

• Head of study: Professor Philipp Wild, MD
                       Professor Thomas Münzel, MD

Summary


Cardiovascular diseases are a major health burden and the leading cause of death in both sexes in Europe. Coronary artery disease takes the first place among these diseases.

The ProsPECTUS study is a single-center, prospective cohort study that investigates comprehensive patient data in a system-oriented approach in order to assess complex interrelations. Patients, who are admitted to the chest pain unit of the University Medical Center Mainz with acute thoracic pain, are included in the study. The aim is to examine the prognostic impact of potential risk factors in a holistic approach and to optimize clinical management strategies in the chest pain unit.

Records of the clinical anamnesis, examinations and therapy data are merged with data on complications and sociodemographic, environmental and personal factors. In a holistic approach the influences of lifestyle, nutrition, physical activity, personality, psychological burden and quality of life as determinants of outcome are considered. In order to establish a long-term resource for comprehensive research in the field of chest pain, a detailed biobanking and a databank will be set up. Among the study related procedures there is an additional blood sampling for the biobanking within the context of routine blood sampling and a paper-based questionnaire, which will be filled in by the patient during hospitalization. The blood samples allow the analysis of genetic patterns and biomarkers for individualized risk stratification and an adapted therapy.

Since May 2014 approximately 1,300 patients aged ≥ 18 years are being recruited per year. The duration of the observation is 5 years starting from the study inclusion date. The completion of a study diary for the first year of observation and regular computer-assisted telephone interviews are part of the active follow-up in the first year. The telephone interviews will be conducted after one, six and twelve months. During these interviews, the participants will be asked about symptoms, medical treatment and changes in quality of life. In the following four consecutive years (year 2, 3, 4 and 5) passive follow-ups will be conducted every year by checking the participants’ vital status via the Registry Offices. The vital status of the patient will also be asked in the context of the active follow up 6 and 12 months after discharge.

Sponsor: Preventive Cardiology and Preventive Medicine, Department of Medicine 2, UMC Main, Network: DZHK Rhine-Main Center, Location Mainz
Speaker of location: Professor Philipp Wild, MD, University Medical Center, Johannes Gutenberg University Mainz

Study Design	Monocentric, prospective, cohort study with detailed biobanking to evaluate diagnostic and therapeutic options in the Chest Pain Unit
Official Title	Prospective, cohort study for the evaluation of diagnostic and therapeutic strategies of acute thoracic pain in the Chest Pain Unit
Status	Recruiting
Steering Committee	Philipp Wild, Mainz, Thomas Münzel, Mainz, Tommaso Gori, Mainz, Ulrich Hink, Mainz, Eberhard Schulz, Mainz, Philip Wenzel, Mainz
Study Management	Charis Mamilou, Mainz