An observational study in Acute Coronary Syndrome and Myocardial Infarction, sponsored by J.M. ten Berg. Recruiting at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by J.M. ten Berg · Observational
Rationale: Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve cardiovascular care, research is needed. Current guidelines are mainly based on well controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing. In order to evaluate the impact and to overcome certain limitations of RCT's, a more practical approach is required. In this sense the use of nonrandomized observational studies is an important tool for determining the effectiveness of a therapy in routine clinical practice. One way to gain insight in characteristics of patients presenting in daily clinical practice, is to simply register these characteristics in a prospective manner with adequate follow up.
Objective: To create an ongoing registry for evaluation of clinical long-term impact of diagnostics, various treatments and devices used for ACS, for research and evaluation of quality of care and to evaluate and improve regional quality of care and cooperation between PCI and non-PCI centers.
Rationale:
Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve cardiovascular care, research is needed. Current guidelines are mainly based on well controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing. Different clinical settings, non-ideal therapy adherence and broader patient populations in the real world than those studied in traditional RCTs may however provide different results. Furthermore, RCTs are intrinsically limited to answer questions about a specific population of interest, require substantial resource investments and may have limitations in investigating certain issues for ethical reasons.
In order to evaluate the impact and to overcome certain limitations of RCT's, a more practical approach is required. In this sense the use of nonrandomized observational studies is an important tool for determining the effectiveness of a therapy in routine clinical practice. One way to gain insight in characteristics of patients presenting in daily clinical practice, is to simply register these characteristics in a prospective manner with adequate follow up. These characteristics may include clinical parameters but also possibly genetic information. Such a detailed registry is now possible due to improvements in information technology, as electronic patient records permit more (semi-) automatic and uniform capture of clinical parameters and outcomes. While observational studies may often be limited in their ability to account for confounding and bias due to patient selection, recent evidence has shown that by careful use of advanced statistical analytical methods and open reporting paradigms the quality of the level of evidence is excellent.
Objectives:
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's planned enrollment of 99,999 is above the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →J.M. ten Berg is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted to the hospital ward with acute coronary syndrome or symptoms suggestive for acute coronary syndrome are invited to participate in the registry.
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:
Number of participants with
* All-cause mortality * Myocardial infarction * Stent thrombosis * Stroke * Revascularisation * All bleeding requiring medical evaluation
Time frame: 3 years
Number of participants with
* mortality classification into cause-of-death (i.e cardiovascular, cardiac, vascular, cerebrovascular, death due to bleeding) * bleeding classification according to different bleeding criteria (i.e. TIMI, BARC, GUSTO, PLATO) * cessation (and duration) of antiplatelet therapy after ACS * patient related outcome measures, as reported in quality of life questionnaires (e.g. SF-12, Seattle Angina Questionnaires)
Time frame: 3 years
Plan to share: Undecided
Started Jan 2015 (actual). Primary completion is estimated for Jun 2050, 425 months after the start.
Of 237 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 425 months is above that.
Counting every sponsor, half of 274 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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J.M. ten Berg