Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease.

  • STATUS
    Recruiting
  • End date
    Dec 23, 2021
  • participants needed
    2000
  • sponsor
    Bispebjerg Hospital
Updated on 23 January 2021
artery disease
myocardial infarction
infarct

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 disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.

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 guidelines. The CADScorSystem may be an efficient, fast and low-cost diagnostic tool with a high rule-out efficiency. The current study aims to investigate if the CADScorSystem can be added as a rule-out test in patients referred with suspected stable CAD to reduce unnecessary testing

Study Hypothesis:

A Diamond-Forrester score plus CAD-score guided rule-out strategy is superior to a Diamond-Forrester score guided strategy alone in reducing diagnostic procedures and non-inferior in terms of safety outcomes in patients with symptoms suggestive of stable coronary artery disease.

Study Setting:

This study will enrol patients without known CAD who are referred with symptoms suggestive for stable CAD for outpatient evaluation at the participating sites. All patients will be symptomatic and require evaluation for suspected CAD. Thus, whether or not the patient chooses to participate in the study, the patient will undergo evaluation for suspected CAD. All the standard NIT modalities and ICA in the study are clinically well established and performed routinely and safely. Experimental testing involves the CADScorSystem, for ruling out CAD before any NIT in the intervention group.

End of Study:

The study will end when all the following have occurred: (1) at least 2000 patients have been randomized, and (2) 121 months (1 year) have elapsed since the last patient was randomized.

Extended Follow-up after Study Termination:

Follow-up might be performed for up to 10 years after randomization. Follow-up information will be extracted from national registers, including information on cardiovascular events and treatments, hospitalizations and ambulatory visits due to cardiovascular events, and causes of death.

Statistical methods:

A detailed description of the planned statistical analyses will be documented in a separate statistical report and analysis plan (SAP), which will be completed before data base lock.

Sample size considerations:

A reduction of 15% or more in the primary endpoint is regarded as clinically significant. Assuming an alpha significance level of 0.05, a statistical power of 80% and an expected number of NIT/ICA of 0.94 per patient in the standard care group, a sample size of 314 patients in each arm is needed to ascertain superiority of the intervention.

A sample size of 1914 provides 90% power for testing non-inferiority in terms of MACE between the two testing strategies, at an alpha significance level of 0.05.

We choose to include 2000 patients, i.e. 1000 patients in each group, allowing for a 4% loss to follow-up and drop out and providing power for the primary endpoint and the secondary MACE non-inferiority endpoint.

Statistical analysis:

The full analysis set (FAS) will include all randomized patients in whom written informed consent was obtained and in accordance with the intention-to-treat principle all patients will be analysed according to the allocated treatment group.

The per-protocol set (PPS) will include only those patients from the FAS who did not have one of the following major protocol violations: inclusion criteria not met, exclusion criteria met, no DF-score calculation, or no CAD-score measurement (intervention group only). Patients who did not receive the randomly allocated CAD-score measurement will be included and analysed in the control group (per protocol analysis).

Details
Condition Stable Angina, Stable Angina Pectoris, Angina, Stable, Angina, Stable
Treatment CADScor®System
Clinical Study IdentifierNCT04121949
SponsorBispebjerg Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 30 yrs?
Gender: Male or Female
Do you have Angina, Stable?
Do you have any of these conditions: Angina, Stable or Stable Angina or Stable Angina Pectoris?
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 Criteria

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
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