Future Optimal Research and Care Evaluation (FORCE-ACS)

January 29, 2019 updated by: J.M. ten Berg

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)

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dean R.P.P. Chan Pin Yin, MD
Phone Number: 088 - 320 12 28
Email: d.chanpinyin@antoniusziekenhuis.nl

Study Contact Backup

Name: Jur M. Ten Berg, MD, PhD
Phone Number: 088 - 320 13 82
Email: j.ten.berg@antoniusziekenhuis.nl

Study Locations

Netherlands
- Gelderland
  - Apeldoorn, Gelderland, Netherlands, 7334 DZ
    - Recruiting
    - Gelre Ziekenhuizem
    - Contact:
      
      D. M. Nicastia, MD
  - Arnhem, Gelderland, Netherlands, 6815 AD
    - Recruiting
    - Rijnstate Arnhem
    - Contact:
      
      R. M. Tjon, MD
  - Ede, Gelderland, Netherlands, 6716 RP
    - Recruiting
    - Gelderse Vallei
    - Contact:
      
      R. Walhout, MD, PhD
  - Tiel, Gelderland, Netherlands, 4002 WP
    - Recruiting
    - Ziekenhuis Rivierenland
    - Contact:
      
      J. Langerveld, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

All patients presenting with ACS
Age ≥ 18 years

Exclusion Criteria:

No oral or signed informed consent available.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Time Frame: 3 years	All-cause mortality Myocardial infarction Stent thrombosis Stroke Revascularisation All bleeding requiring medical evaluation	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Time Frame: 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)	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

J.M. ten Berg

Collaborators

AstraZeneca

St. Antonius Hospital

ZonMw: The Netherlands Organisation for Health Research and Development

Vereniging Hart-Beter

Investigators

Study Chair: Johan Dekker, Drs., St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ANTICIPATED)

June 30, 2050

Study Completion (ANTICIPATED)

June 30, 2050

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (ACTUAL)

January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)