Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

Contains fulltext : 70525.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND -: Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. METHODS/DESIGN -: In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse(R) Boehringer Ingelheim GmbH), a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year.The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. DISCUSSION -: The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage. TRIAL REGISTRATION -: Trialregister NTR161

Randomised controlled trial of a psychiatric consultation model for treatment of common mental disorder in the occupational health setting

BACKGROUND: Common mental disorders are the most prevalent of all mental disorders, with the highest burden in terms of work absenteeism and utilization of health care services. Evidence-based treatments are available, but recognition and treatment could be improved, especially in the occupational health setting. The situation in this setting has recently changed in the Netherlands because of new legislation, which has resulted in reduced sickness absence. Severe mental disorder has now become one of the main causes of work absenteeism. Occupational physicians (OPs) are expected to take an active role in diagnosis and treatment, and seem to be in need of support for a new approach to handle cases of more complex mental disorders. Psychiatric consultation can be a collaborative care model to achieve this. METHODS/DESIGN: This is a two-armed cluster-randomized clinical trial, with randomization among OPs. Forty OPs in two big companies providing medical care for multiple companies will be randomized to either the intervention group, i.e. psychiatric consultation embedded in a training programme, or the control group, i.e. only training aimed at recognition and providing Care As Usual. 60 patients will be included who have been absent from work for 6–52 weeks and who, after screening and a MINI interview, are diagnosed with depressive disorder, anxiety disorder or somatoform disorder based on DSM-IV criteria. Baseline measurements and follow up measurements (at 3 months and 6 months) will be assessed with questionnaires and an interview. The primary outcome measure is level of general functioning according to the SF-20. Secondary measures are severity of the mental disorder according to the PHQ and the SCL-90, quality of life (EQ-D5), measures of Return To Work and cost-effectiveness of the treatment assessed with the TiC-P. Process measures will be adherence to the treatment plan and assessment of the treatment provided by the Psychiatric Consultant (PC) in both groups. DISCUSSION: In the current study, a psychiatric consultation model that has already proved to be effective in the primary care setting, and aimed to enhance evidence-based care for patients with work absenteeism and common mental disorder will be evaluated for its efficacy and cost-effectiveness in the occupational health setting

Space/time tectono-sedimentary evolution of the Umbria-Romagna-Marche Miocene Basin (Northern Apennines, Italy): a foredeep model.

The space/time evolution of the Umbria-Romagna-Marche domains of the northern Apennine Miocene foredeep is proposed. In this period, the turbidite siliciclastic sedimentation is represented mainly by the Miocene Marnoso-Arenacea Formation, which generally ends with mainly marly deposits. From the internal Apennine sectors (Umbria-Romagna domain) to the external Adriatic Margin (Marche domain) the siliciclastic succession overlies hemipelagic marly deposits (Schlier Formation). The whole depositional area can be considered as a single wide basin with depocenter or main sedimentation areas progressively migrating eastwards. This basin is characterized by some morphological highs which did not constitute real dams for the sedimentary flow(turbidity currents). Multiple feeding (arkose, litharenites, calcarenites) from different sources is related to palaeogeographical and palaeotectonic reorganization of the most internal, previously deformed, Apennine areas. The activation of the foredeep stage is marked by the beginning of the siliciclastic sedimentation (Late Burdigalian in the most internal sector). This sedimentation ends in the most external sector in the Early Messinian, pointing to a depositional cycle of about 9–10 Ma. The diachronism of the base of the siliciclastic deposition proves to be almost 5 Ma. The syn-depositional compressional deformation, which shows a marked diachronism, affected the internal area of the foredeep in the Early-Middle Serravallian, and progressively migrated up to Late Miocene, involving more and more external sectors. The deformed siliciclastic sedimentary wedge constitutes an orogenic pile incorporated in the Apennine Chain, represented by different tectonic elements superimposed by means of NE-vergent thrusts. The main stratigraphic and tectonic events of the Toscana-Romagna-Marche Apennines are presented in a general framework,resulting also in a terminological revision