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)

Overview

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

Primary outcome measures

• Number of participants with [Time frame: 3 years]

Secondary outcome measures (1)

• Number of participants with [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• All patients presenting with ACS
• Age ≥ 18 years

Exclusion criteria

• No oral or signed informed consent available.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 4 centers

• Gelre Ziekenhuizem — Apeldoorn
• Rijnstate Arnhem — Arnhem
• Gelderse Vallei — Ede
• Ziekenhuis Rivierenland — Tiel

Publications

• van den Broek WWA, Azzahhafi J, van de Pol QYF, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Peper J, Harmsze AM, Walhout RJ, Tjon Joe Gin M, Breet NJ, Langerveld J, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, Ten Berg JM. Genotype-Guided P2Y12-Inhibitor De-Escalation Strategy in Acute Coronary Syndrome: Observational Evidence From the POPular-GUIDE PCI. Circ Cardiovasc Interv. 2 PMID 41744086
• van den Broek WWA, Azzahhafi J, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Dijksman LM, Walhout RJ, Tjon Joe Gin M, Breet NJ, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, Ten Berg JM. Cost-effectiveness of implementing a genotype-guided de-escalation strategy in patients with acute coronary syndrome. Eur Heart J Cardiovasc Pharmacoth PMID 39537191
• 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. PMID 35354660
• 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 "Pe PMID 33007932

Identifiers

NCT: NCT03823547 · Hart Beter/FORCE-ACS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗