Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04121949
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2019-10-09
Brief Title:
Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
A Prospective Randomized Controlled Parallel-group Multicentre Trial to Examine the Cost-effectiveness and Safety of Adding the CADScorSystem as a Rule-out Test in Patients Referred With Symptoms Suggestive of Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FILTER-SCAD
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 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
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 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 005 a statistical power of 80 and an expected number of NITICA of 094 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 005
We choose to include 2000 patients ie 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
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 005 a statistical power of 80 and an expected number of NITICA of 094 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 005
We choose to include 2000 patients ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None