An observational study in NSTEMI - Non-ST Segment Elevation MI, sponsored by Marco Marchetti. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-26.
Sponsored by Marco Marchetti · Observational
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Among 36 studies in Non-ST Elevated Myocardial Infarction with a site in Italy — 3 open to participants now, 8 under way, none of them phase 3. Non-ST Elevated Myocardial Infarction · Italy.
Among the 36 studies in Non-ST Elevated Myocardial Infarction with a site in Italy, this one is the 2nd largest by enrollment of the 13 observational ones that give a count, is the only one that started in 2017, is one of 13 observational ones, and was the 21st registered.
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
Browse Non-ST Elevated Myocardial Infarction studies →3 of the 36 studies in Non-ST Elevated Myocardial Infarction with a site in Italy are open now. Recruiting first, the newest first:
Heart Care Foundation · Sites in Italy
Ages 18+
Catholic University of the Sacred Heart · Sites in Italy
Ages 18+
Centro Cardiopatici Toscani · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 40 Non-ST Elevated Myocardial Infarction studies recruiting now, 34 (85%) set no upper age limit and 1 (3%) stops at 75 or younger; 4 take children under 18; 2 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.
36 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,913 is above the median of 525 across 130 observational studies indexed under Non-ST Elevated Myocardial Infarction.
Median enrollment 1,139 across the 23 interventional studies, 800 across the 13 observational. Of the 16 that completed or were terminated, 6 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 36 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Marco Marchetti as lead sponsor.
Marco Marchetti has 1 study filed under Non-ST Elevated Myocardial Infarction — fewer than ten, so there is no comparison to draw.
1 of the studies in Non-ST Elevated Myocardial Infarction with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07283809Heart Care FoundationEuropean Unified Registries for Heart Care Evaluation and Randomised Trials Italy | 2027-09-15 |
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Among the 36 studies in Non-ST Elevated Myocardial Infarction with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Myocardial infarction is one of the leading causes of death and disability worldwide. In addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and assume a central role for both exclusion ("rule out") and confirmation ("rule in") of acute myocardial infarction , while allowing to reduce the time interval between ER admission and presumptive diagnosis.
Considering the relevance of this topic, we propose to conduct an observational study in real world clinical practice settings at Emergency Departments, aiming to evaluate clinical and economic aspects deriving from the use of the different quantitative assays of high-sensitivity cardiac troponin currently available in patients with suspected acute myocardial infarction and non-ST-elevation ECG (NSTEMI) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.
Observational, prospective, real-world clinical practice, multicentric study, conducted at 12 Emergency Departments in Italy.
Patients with suspected non-ST-elevation myocardial infarction (NSTEMI) who have undergone at least one high-sensitivity cardiac troponin test will be included.
Patients will be enrolled in the study after verification of selection criteria.
Enrollment is consecutive; each Center will suspend enrollment when it has reached the expected number of patients.
An electronic data collection form (eCRF) will be used to automatically generate an enrollment number to identify each patient.
Given the observational nature of the study, high-sensitivity cardiac troponin assays will be used according to current clinical practice.
Patients will be examined in the ED, and on a 30-day follow-up.
Patients attending the Emergency Department with chest pain
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Time to diagnosis in the emergency department
Time from admission at the emergency department and diagnosis or exclusion of NSTEMI
Time frame: 1-3-6 hours
Number of ruled-in and ruled-out patients
Number of patients diagnosed with NSTEMI and hospitalized, and number of patients discharged from the emergency room after exclusion of NSTEMI
Time frame: 1-3-6 hours
Number of tests performed
Number of high-sensitivity cardiac troponin tests performed
Time frame: 1-3-6 hours
Number of patients diagnosed with a Major Adverse Clinical Event
number of patients with myocardial infarction, stroke, or unplanned revascularization
Time frame: 30 days after the first assessment
30-day mortality
Death rate 30 days after admission to the emergency department
Time frame: 30 days following admission
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2018, 9 months.
Of 54 non-industry observational studies under Non-ST Elevated Myocardial Infarction, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 86. This study's 9 months is below that.
Counting every sponsor, half of 76 studies reached it within 32 months; a quarter within 19 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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