An observational study in Chest Pain, Acute Coronary Syndrome and Myocardial Infarction, sponsored by Ulf Ekelund. Completed at 5 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Ulf Ekelund · Observational
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Among 13 studies in Angina, Unstable with a site in Sweden — none open to participants now, none under way, none of them phase 3. Angina, Unstable · Sweden.
Among the 13 studies in Angina, Unstable with a site in Sweden, this one is the only one that started in 2018, is one of 2 observational ones, and was the 11th registered.
328 studies on the registry are indexed under Angina, Unstable; 42 are open to participants now.
Browse Angina, Unstable studies →None of the 13 studies in Angina, Unstable with a site in Sweden is open now. The open studies under Angina, Unstable, anywhere →
Of the 34 Angina, Unstable studies recruiting now, 29 (85%) set no upper age limit and 3 (9%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16,000 is above the median of 982 across 121 observational studies indexed under Angina, Unstable.
Median enrollment 1,101 across the 11 interventional studies, 8,008 across the 2 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 13 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Ulf Ekelund as lead sponsor.
Ulf Ekelund has 1 study filed under Angina, Unstable — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Angina, Unstable with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown.
The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
STUDY DESIGN:
ESC-TROP is a before-and-after implementation study with concurrent controls that will evaluate the safety and effectiveness of a 0h/1h hs-cTnT protocol. The intervention group will consist of ED chest pain patients enrolled during 10 months after implementation of this protocol in routine care at the three intervention sites, and the control groups will be chest pain patients managed at the same EDs during the corresponding 10 months of the previous year, as well as chest pain patients managed during the same before-and-after period at two EDs not implementing the protocol (concurrent controls).
OBJECTIVES:
To determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
ELIGIBILITY CRITERIA:
All patients with an ED visit with a primary complaint of non-traumatic chest pain will be identified through the electronic ED patient log and screened for eligibility.
IMPLEMENTED PROTOCOL:
ESC guidelines state that the 0h/1h hs-cTnT protocol should be used in conjunction with clinical assessment and the ECG, and these items are therefore incorporated in the protocol, which also reflects real-life practice. A 1h hs-cTnT is defined as a second hs-cTnT sample drawn 45 - 90 minutes from the sample at presentation (0h).
OUTCOMES:
Se outcomes section. Outcomes will be compared in the 10-month periods before and after the implementation at all five hospitals, and the differences in change will be compared between intervention and control hospitals.
FOLLOW-UP:
Follow-up will be performed using data from a comprehensive regional electronic patient record system as well as Swedish national registries.
DATA MANAGEMENT AND STATISTICAL ANALYSES:
Data management and statistical analyses will be performed by Clinical Studies Sweden, Forum South. For the primary safety outcome, event rate after implementation (intervention group) will be compared to event rate in the control period using a non-inferiority approach
SAMPLE SIZE:
If it is assumed that the event rate is 0.4% among discharged patients in the control period and 0.5% after implementation, 4396 discharged patients would be needed both before and after the implementation (i.e. a total of 8792) to statistically determine that the event rate after implementation is non-inferior to that in the control period, with a two-sided alpha risk of 0.05 and a power of 0.80. The non-inferiority margin has been set to 0.5 percentage units as there is consensus that a \<1% incidence of AMI/death within 30 days represents good safety for a diagnostic strategy in chest pain patients.
Based on a total of 13100 annual chest pain patients at the three EDs and a 25% exclusion rate, a study period of 10 months will give enrollment of about 8200 patients. If 55% are discharged from the ED, about 4500 patients will be discharged both before and after implementation (i.e. a total of about 9000).
With this sample size, and an estimated median ED length of stay (LOS) in discharged patients in the control group of 240 minutes, it will be possible to detect a difference in ED LOS of about 14 minutes with a power of 0.80 and alpha of 0.05. This sample size will thereby provide adequate power to detect a clinically significant difference in ED LOS for the co-primary outcome.
328 studies on the registry are indexed under Angina, Unstable; 42 are open to participants now.
This study's enrollment of 16,000 is above the median of 982 across 121 observational studies indexed under Angina, Unstable.
Browse Angina, Unstable studies →This is the only study on the registry with Ulf Ekelund as lead sponsor.
Compared within Angina, Unstable, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chest Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All ED patients with a primary complaint of chest pain will be screened for eligibility
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Chest pain patients enrolled during a 10 month period after a change in routine care, i.e. the implementation of a 0h/1h hs-cTnT protocol
Other: 0h/1h hs-cTnT protocol
Chest pain patients managed at the 3 intervention EDs during the corresponding 10 months of the previous year (intervention hospitals acting as their own controls) as well as chest pain patients managed during the corresponding before-and-after period at EDs not implementing the protocol (concurrent controls).
Implementation of a 0h/1h hs-cTnT protocol in routine care
AMI and all-cause death
Comparison of the rate of AMI and all-cause death within 30 days from ED presentation in patients discharged from the ED during the intervention period versus the control period (safety)
Time frame: 30 days from ED presentation
ED length of stay
Comparison of ED length of stay in patients discharged from the ED during the intervention period versus the control period (effectiveness)
Time frame: Through discharge from the ED, on average 5 hours after ED presentation
Proportion of ED patients discharged
Comparison of the proportion of patients discharged from the ED during the intervention period versus the control period
Time frame: Through discharge from the ED, on average 5 hours after ED presentation
Proportion of patients fulfilling 0h/1h hs-cTnT criteria who have undergone objective testing
Proportion of patients fulfilling 0h/1h hs-cTnT criteria (0h hs-cTnT \<5 ng/L or a 0h hs-cTnT \<12 ng/L with a 1h increase \<3 ng/L) who have undergone objective testing (exercise stress test, myocardial perfusion imaging, CT coronary angiography, coronary angiography) within 30 days during the intervention period.
Time frame: 30 days from ED presentation
Non-ACS coronary care unit admissions
Comparison of the proportion of patients without acute coronary syndrome (ACS) admitted to the coronary care unit during the intervention period versus the control period.
Time frame: Throughout index hospital visit, on average 2 days after ED presentation
Inappropriate coronary angiographies
Comparison of the proportion of patients who undergo inappropriate coronary angiographies during the intervention period versus the control period
Time frame: Throughout index hospital visit, on average 2 days after ED presentation
Total hospital length of stay
Comparison of total hospital length of stay during the intervention period versus the control period.
Time frame: Through discharge from the index hospital visit, on average 2 days after ED presentation
ED revisits
Comparison of the proportion of patients with 30-day ED revisits during the intervention period versus the control period.
Time frame: 30 days from ED presentation
New admissions
Comparison of the proportion of discharged patients with admissions to inpatient care within 30 days during the intervention period versus the control period.
Time frame: 30 days from ED presentation
Health care costs
Comparison of health care costs within 30 days during the intervention period versus the control period. These data will be presented in a separate sub-study.
Time frame: 30 days from ED presentation
Ran from Feb 2018 to primary completion in Dec 2018, 10 months.
Of 51 non-industry observational studies under Angina, Unstable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 86. This study's 10 months is below that.
Counting every sponsor, half of 62 studies reached it within 38 months; a quarter within 19 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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