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Future Optimal Research and Care Evaluation (FORCE-ACS)

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ClinicalTrials.gov Identifier: NCT03823547
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Vereniging Hart-Beter
St. Antonius Hospital
ZonMw: The Netherlands Organisation for Health Research and Development
AstraZeneca
Information provided by (Responsible Party):
J.M. ten Berg, St. Antonius Hospital

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
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:

  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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 99999 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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 : January 1, 2015
Estimated Primary Completion Date : June 30, 2050
Estimated Study Completion Date : June 30, 2050



Primary Outcome Measures :
  1. Number of participants with [ Time Frame: 3 years ]
    • All-cause mortality
    • Myocardial infarction
    • Stent thrombosis
    • Stroke
    • Revascularisation
    • All bleeding requiring medical evaluation


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • All patients presenting with ACS
  • Age ≥ 18 years

Exclusion Criteria:

  • No oral or signed informed consent available.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823547


Contacts
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Contact: Dean R.P.P. Chan Pin Yin, MD 088 - 320 12 28 d.chanpinyin@antoniusziekenhuis.nl
Contact: Jur M. Ten Berg, MD, PhD 088 - 320 13 82 j.ten.berg@antoniusziekenhuis.nl

Locations
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Netherlands
Gelre Ziekenhuizem Recruiting
Apeldoorn, Gelderland, Netherlands, 7334 DZ
Contact: D. M. Nicastia, MD         
Rijnstate Arnhem Recruiting
Arnhem, Gelderland, Netherlands, 6815 AD
Contact: R. M. Tjon, MD         
Gelderse Vallei Recruiting
Ede, Gelderland, Netherlands, 6716 RP
Contact: R. Walhout, MD, PhD         
Ziekenhuis Rivierenland Recruiting
Tiel, Gelderland, Netherlands, 4002 WP
Contact: J. Langerveld, MD, PhD         
Sponsors and Collaborators
J.M. ten Berg
Vereniging Hart-Beter
St. Antonius Hospital
ZonMw: The Netherlands Organisation for Health Research and Development
AstraZeneca
Investigators
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Study Chair: Johan Dekker, Drs. St. Antonius Hospital

Additional Information:

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Responsible Party: J.M. ten Berg, Principle investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03823547     History of Changes
Other Study ID Numbers: Hart Beter/FORCE-ACS
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J.M. ten Berg, St. Antonius Hospital:
Platelet aggregation inhibitors
DAPT
Dual Antiplatelet Therapy
Myocardial infarction
Acute Coronary Syndrome
Ticagrelor
Prasugrel
Clopidogrel
Thrombosis
Myocardial Ischemia
Risk scores
Cardiovascular diseases

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases