Cardiogenic shock is a serious complication of a heart attack seen in 5-7% of patients. Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), the short term mortality in patients with cardiogenic shock still exceeds 50%.
An alternative to the current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella-device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby augmenting blood flow to the failing organs. In 2012 a more powerful Impella pump has been introduced that is able to deliver up to 3.5l/min (approximately 75% of a normal cardiac output at rest).
The vision of the DanShock study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella device. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to conventional management or support with the Impella-device.
A total of 360 patients will be enrolled at 4 invasive tertiary centers in Denmark. The primary endpoint will be death from all causes.
Patient enrollment is ongoing and the study is expected to be finalized in 2018.
The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease.
Population based randomized clinically controlled screening trial.
Participants: 45,000 Danish men aged 65-74 years living on the Island of Funen, or the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used.
Interventions: One-third will be invited to cardiovascular 7-faceted screening examinations at one of 4 locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive finding.
Objective: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective.
Outcome: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome)
Randomization: Each of the 45,000 individual is by EPIDATA given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as control group.
Blinding: Only those randomized to the screening will be invited to the examination, while the remaining participants will not.
Numbers randomized: A total of 45,000 men will be randomized 1:2
Recruitment: Enrollment started October 2014
Outcome: A 5% reduction in overall mortality (HR=0.95) with the risk for a type 1 error=5% and the risk for a type II error=80% is expected. We expect a two-year enrolment, a 10 year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%.
Current Controlled Trials:ISRCTN12157806 (21th of March 2015)
Cardiovascular prevention, screening, aortic aneurysm, coronary calcium score, atrial fibrillation, peripheral arterial disease, benefit, cost effectiveness, public health.