Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04939207
Status:
RECRUITING
Last Update Posted:
2022-05-19
First Post:
2021-06-07
Brief Title:
Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
Improving the Cost-effectiveness Of Coronary Artery Disease Diagnosis
Status:
RECRUITING
Status Verified Date:
2022-05
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:
iCORONARY
Brief Summary:
Yearly 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease CAD To assess this multiple diagnostic tests are available Non-invasive imaging tests such as coronary CT-scan are safe relatively cheap and can effectively rule-out CAD However when CAD is present coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow This is an invasive test more expensive than CT and it is accompanied by certain risks
Most patients in whom CAD is present do not need treatment and would therefore benefit from non-invasive diagnostic tests To reduce the number of unnecessary cardiac angiography with flow measurements new imaging techniques have been developed These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan
Subjects are eligible if their CT-scan indicates possibly significant CAD To determine need for treatment of a subjects CAD the investigators will randomize subjects in three arms One arm consists of additional CT-derived calculation of coronary blood flow one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care coronary angiography and invasive coronary blood flow measurements After these tests subjects are treated and followed according to routine care guidelines Additionally subjects are requested to complete 5 questionnaires in a 12 month follow-up period
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques The investigators expect that this will lead to a reduction in healthcare costs complications and a lower burden of diagnostic tests for patients The investigators do not expect a difference in primary endpoints between the study groups
Most patients in whom CAD is present do not need treatment and would therefore benefit from non-invasive diagnostic tests To reduce the number of unnecessary cardiac angiography with flow measurements new imaging techniques have been developed These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan
Subjects are eligible if their CT-scan indicates possibly significant CAD To determine need for treatment of a subjects CAD the investigators will randomize subjects in three arms One arm consists of additional CT-derived calculation of coronary blood flow one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care coronary angiography and invasive coronary blood flow measurements After these tests subjects are treated and followed according to routine care guidelines Additionally subjects are requested to complete 5 questionnaires in a 12 month follow-up period
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques The investigators expect that this will lead to a reduction in healthcare costs complications and a lower burden of diagnostic tests for patients The investigators do not expect a difference in primary endpoints between the study groups
Detailed Description:
Only a small proportion of the 180 000 patients that are referred to a cardiologist each year in the Netherlands with complaints of angina pectoris or shortness of breath suffer from coronary stenosis in such a degree that revascularisation is required To identify these patients multiple diagnostic tests are available Simple non-interventional imaging tests such as coronary CT-scan are safe relatively cheap and can effectively rule-out coronary artery disease However when coronary artery disease is present coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow This is an invasive test more expensive than CT and it is accompanied by certain risks
In retrospect many patients unnecessarily undergo cardiac angiography with if deemed neccessary flow measurements These patients do not need treatment for coronary artery disease To reduce the number of unnecessary cardiac angiography with flow measurements new imaging techniques have been developed These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment These new imaging techniques have been tested extensively in observational studies Currently there is no consensus in the optimal diagnostic pathway resulting in major differences in strategies between hospitals Moreoverdata on cost-effectiveness is lacking
This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan Our target population will be patients with complaints of angina pectoris or shortness of breath for which the patients will undergo coronary CT-scan If the CT-scan shows one or more possibly flow-limiting stenoses further diagnostic testing is required These subjects are randomized in one of three possible arms One arm will receive additional CT-derived calculation of coronary blood flow one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard care Standard care consists of coronary angiography and invasive coronary blood flow measurements The results of these tests determine the need for treatment of coronary artery disease After these tests subjects are treated according to routine care guidelines Subjects are requested to complete 5 questionnaires in a 12 month follow-up period The primary endpoint is a composite of MACE - all-cause mortality aborted sudden cardiac death myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization during the 12-month follow-up period Secondary endpoints consist of cost-effectiveness the number of avoided invasive coronary angiographies and flow measurements and quality of life The investigators will use hospital patient files and completed questionnaires to collect information about events during the follow-up period until the last included subject has completed their final questionnaire
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques The investigators expect that this will lead to a reduction in healthcare costs complications and a lower burden of diagnostic tests for patients The investigators do not expect a difference in primary endpoints between the study groups
In addition to the randomised controlled trial all eligible subjects whose coronary CT-scan does not show possibly significant coronary artery disease CAD-RADS 0-2 are included in a patient registry Because of absent or limited coronary artery disease additional diagnostic testing is not needed in these patients These subjects are requested to answer 5 questionnaires in a 12-month period similar to the subjects included in the RCT-part of the trial The outcome measures of this part of the trial are similar to those of the RCT Our primary outcome is the occurrence of MACE-events secondary outcomes are quality of life and patient satisfaction
In retrospect many patients unnecessarily undergo cardiac angiography with if deemed neccessary flow measurements These patients do not need treatment for coronary artery disease To reduce the number of unnecessary cardiac angiography with flow measurements new imaging techniques have been developed These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment These new imaging techniques have been tested extensively in observational studies Currently there is no consensus in the optimal diagnostic pathway resulting in major differences in strategies between hospitals Moreoverdata on cost-effectiveness is lacking
This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan Our target population will be patients with complaints of angina pectoris or shortness of breath for which the patients will undergo coronary CT-scan If the CT-scan shows one or more possibly flow-limiting stenoses further diagnostic testing is required These subjects are randomized in one of three possible arms One arm will receive additional CT-derived calculation of coronary blood flow one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard care Standard care consists of coronary angiography and invasive coronary blood flow measurements The results of these tests determine the need for treatment of coronary artery disease After these tests subjects are treated according to routine care guidelines Subjects are requested to complete 5 questionnaires in a 12 month follow-up period The primary endpoint is a composite of MACE - all-cause mortality aborted sudden cardiac death myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization during the 12-month follow-up period Secondary endpoints consist of cost-effectiveness the number of avoided invasive coronary angiographies and flow measurements and quality of life The investigators will use hospital patient files and completed questionnaires to collect information about events during the follow-up period until the last included subject has completed their final questionnaire
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques The investigators expect that this will lead to a reduction in healthcare costs complications and a lower burden of diagnostic tests for patients The investigators do not expect a difference in primary endpoints between the study groups
In addition to the randomised controlled trial all eligible subjects whose coronary CT-scan does not show possibly significant coronary artery disease CAD-RADS 0-2 are included in a patient registry Because of absent or limited coronary artery disease additional diagnostic testing is not needed in these patients These subjects are requested to answer 5 questionnaires in a 12-month period similar to the subjects included in the RCT-part of the trial The outcome measures of this part of the trial are similar to those of the RCT Our primary outcome is the occurrence of MACE-events secondary outcomes are quality of life and patient satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 852002131 | OTHER_GRANT | ZonMW | None |