Status:
COMPLETED
Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease.
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
Region Hovedstadens Apotek
Larix A/S
Conditions:
Angina, Stable
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery...
Detailed Description
Purpose and Rationale for the Study: The declining incidence of obstructive CAD and a good prognosis for patients with stable angina challenges the resource demanding approach recommended in current ...
Eligibility Criteria
Inclusion
- Have signed the informed consent form.
- Males and females, aged 30 years or above.
- Be able and willing to comply with the clinical investigational plan.
- Symptoms suggestive of stable coronary artery disease.
- No history of coronary artery disease (prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Exclusion
- Diamond-Forrester score \>85%.
- Prior non-invasive testing for stable CAD or invasive coronary angiography within 6 months of randomization.
- Implanted donor heart, mechanical heart, mechanical heart pump.
- Pacemaker or Cardioverter Defibrillator (ICD).
- Implanted electronic equipment in the area above and around the heart.
- Significant operation scars, abnormal body shape, fragile or compromised skin in the fourth left intercostal space recording area.
- Receiving same day treatment with nitro-glycerine on the day of randomization.
- Pregnancy.
- The exclusion criteria '1. Diamond-Forrester score \>85%' was removed after updating the study according to the 2019 ESC guidelines on chronic coronary syndrome. According to these current guidelines, no patients should be referred to invasive diagnostic test based on their PTP alone, and therefore is this exclusion criteria is no longer relevant.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
2016 Patients enrolled
Trial Details
Trial ID
NCT04121949
Start Date
July 1 2019
End Date
September 15 2023
Last Update
October 5 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Amager Hospital
Copenhagen S, Denmark, 2300
2
University Hospital Herlev and Gentofte
Herlev, Denmark, 2730
3
University Hospital Nordsjaelland
Hillerød, Denmark, 3400
4
University Hospital Hvidovre
Hvidovre, Denmark, 2650