Cardiogenic ShockSTOP-SHOCKNCT03313687
SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK
An observational study of Cardiogenic Shock, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 31 Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to a tertiary care hospital.
Who may be able to join
- Patients with cardiogenic shock treated at a tertiary care hospital.
Who cannot join
- Age ≤17 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Heart Center
Hamburg
Dirk Westermann, MD
Benedikt Schrage, MD
About this study
Official title: SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK - an International, Observational Registry
International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock.
Read the detailed description
There is a focus on interventional therapies, mechanical circulatory support and new cardiovascular therapeutics in patients with cardiogenic shock (CS). The investigators will describe current practice in study sites including concomitant patients with CS. Therefore, the investigators will monitor drug therapies initiated, devices being utilized as well as outcome and side effect of possible interventions
- Conditions
- Cardiogenic Shock
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
by registration office
Measured: Within 30 days after admission.
Secondary outcomes (3)
Ischemic events, bleeding events, heart failure, sepsis, dialysis.
by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis.
Measured: Within 30 days after admission.
All-cause mortality
by registration office
Measured: Within 12 months after admission.
Ischemic events, bleeding events, heart failure, sepsis, dialysis.
by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis.
Measured: Within 12 months after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Dirk Westermann, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Dirk Westermann, MD, Principal investigator, UHZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313687
- Sponsor's protocol ID
- STOP-SHOCK
- Acronym
- STOP-SHOCK
- Status last verified
- Sep 2021
- First submitted
- 14 Oct 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.
PubMed 30586755