Clinical trial NCT03823547: Future Optimal Research and Care Evaluation
Official title: Future Optimal Research and Care Evaluation: On the Way to "Personalized Medicine" With an Ongoing Registry of Patients in Daily Clinical Practice (Hart Beter/ FORCE-ACS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: DAPT
Dual Antiplatelet Therapy
Myocardial infarction
Acute Coronary Syndrome
Ticagrelor
Prasugrel
Clopidogrel
Thrombosis
Myocardial Ischemia
Platelet aggregation inhibitors
Risk scores
Cardiovascular diseases
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Vereniging Hart-Beter
name: St. Antonius Hospital
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: AstraZeneca
First posted: 2019-01-30
Enrollment: 99999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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. To create a database for future research, especially in the view of personalized medicine, and quality of care.
2. To evaluate clinical long-term impact of medication, devices and diagnostic tools used for patients with an ACS.
3. To test the efficacy and safety of any new drug/device versus the current treatment and the results of any drug/device in daily practice versus in trials
4. To evaluate routine follow-up and current health-care pathways in patients with acute coronary syndrome in the Dutch healthcare system in terms of mortality, recurrent ischemic events, recurrent hospital admissions and quality of life
5. To evaluate the use of risk scores (e.g. PRECISE-DAPT score, DAPT-score) to define the optimal duration of antiplatelet drugs
6. To evaluate follow-up of patients referred to general practitioners as compared to of patients continued to be treated by cardiologists
7. To increase adherence to current guidelines, taking into account the ongoing improvements of modern patient care and future changes of treatment guidelines in patients with ACS in order to improve secondary prevention in terms of reducing recurrent ischemic events and preventing adverse outcomes, such as bleeding

Eligibility criteria: Inclusion Criteria:

* All patients presenting with ACS
* Age ≥ 18 years

Exclusion Criteria:

* No oral or signed informed consent available.

Primary outcomes:
measure: Number of participants with
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with
timeFrame: 3 years
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizem
state: Gelderland
city: Arnhem
country: Netherlands
facility: Rijnstate Arnhem
state: Gelderland
city: Ede
country: Netherlands
facility: Gelderse Vallei
state: Gelderland
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
state: Gelderland
Study officials:
affiliation: St. Antonius Hospital
name: Johan Dekker, Drs.
role: STUDY_CHAIR
References:
citation: van der Sangen NMR, Azzahhafi J, Chan Pin Yin DRPP, Peper J, Rayhi S, Walhout RJ, Tjon Joe Gin M, Nicastia DM, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Ten Berg JM, Kikkert WJ. External validation of the GRACE risk score and the risk-treatment paradox in patients with acute coronary syndrome. Open Heart. 2022 Mar;9(1):e001984. doi: 10.1136/openhrt-2022-001984.
citation: Chan Pin Yin DRPP, Vos GA, van der Sangen NMR, Walhout R, Tjon Joe Gin RM, Nicastia DM, Langerveld J, Claassens DMF, Gimbel ME, Azzahhafi J, Bor WL, Oirbans T, Dekker J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Kikkert WJ, Ten Berg JM. Rationale and Design of the Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome (FORCE-ACS) Registry: Towards "Personalized Medicine" in Daily Clinical Practice. J Clin Med. 2020 Sep 30;9(10):3173. doi: 10.3390/jcm9103173.