FORCE-ACS: Future Optimal Research and Care Evaluation

Sponsor

J.M. ten Berg (Other)

Overall Status

Recruiting

CT.gov ID

NCT03823547

Collaborator

Vereniging Hart-Beter (Other), St. Antonius Hospital (Other), ZonMw: The Netherlands Organisation for Health Research and Development (Other), AstraZeneca (Industry)

99,999

Enrollment

Locations

425.9

Anticipated Duration (Months)

24999.8

Patients Per Site

58.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Myocardial Infarction

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:

To create a database for future research, especially in the view of personalized medicine, and quality of care.
To evaluate clinical long-term impact of medication, devices and diagnostic tools used for patients with an ACS.
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
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
To evaluate the use of risk scores (e.g. PRECISE-DAPT score, DAPT-score) to define the optimal duration of antiplatelet drugs
To evaluate follow-up of patients referred to general practitioners as compared to of patients continued to be treated by cardiologists
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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

99999 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Jun 30, 2050

Anticipated Study Completion Date :

Jun 30, 2050

Outcome Measures

Primary Outcome Measures

Number of participants with [3 years]
All-cause mortality Myocardial infarction Stent thrombosis Stroke Revascularisation All bleeding requiring medical evaluation

Secondary Outcome Measures

Number of participants with [3 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients presenting with ACS
Age ≥ 18 years

Exclusion Criteria:

No oral or signed informed consent available.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gelre Ziekenhuizem	Apeldoorn	Gelderland	Netherlands	7334 DZ
2	Rijnstate Arnhem	Arnhem	Gelderland	Netherlands	6815 AD
3	Gelderse Vallei	Ede	Gelderland	Netherlands	6716 RP
4	Ziekenhuis Rivierenland	Tiel	Gelderland	Netherlands	4002 WP