Ischemic Heart Disease
Conditions
Keywords
IHD, CAD, Non invasive imaging, SPECT, PET, CMR, Echocardiography
Brief summary
Main purpose of the study: To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).
Detailed description
Objectives of the study 1. To test the accuracy of anatomical and functional non-invasive cardiac imaging in the diagnosis of IHD. To this purpose the anatomical information provided by CTA is obtained in every patient together with the functional information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. Non-invasive results are tested against invasive reference standards. The latter consists of invasive coronary angiography integrated by invasive measurement of fractional flow reserve (to assess the hemodynamic relevance of intermediate coronary stenoses). 2. To test the accuracy of integrated models, including clinical variables, risk factors and circulating biomarkers, to predict significant obstructive coronary artery disease in patients with chronic angina-like symptoms. To correlate biohumoral profiles with the coronary anatomical-functional phenotype as obtained by non invasive imaging in the same patients. To reach these goals the clinical characterization of patients (collected before non-invasive imaging) and the laboratory characterization (that includes novel biomarkers of cardiovascular risk) are compared with patient characterization derived from non invasive anatomic-functional imaging and with invasive diagnosis of significantly obstructive coronary disease. 3. To develop an advanced clinical and imaging reporting tool in cardiology. An informatics platform is developed to synthetically and clearly present the integrated clinical and imaging diagnostic profile of individual patients. A multimodal imaging reporting tool is developed including tools for image fusion of different imaging modalities (CT, SPECT, PET, MRI). 4. To define the most cost-effective work-up for the diagnosis and characterization of IHD. To this purpose the costs and the procedural risks (including radiation exposure) of non-invasive and invasive diagnostic procedures are prospectively collected. Cost-benefit and cost-effectiveness analyses is conducted alongside the EVINCI-study clinical trial.
Interventions
OTHERNon invasive cardiac imaging
Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
Sponsors
European Commission
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with intermediate (\>20%, \<90%) risk of IHD based on age,gender,symptoms and exercise stress test results
Exclusion criteria
* Age \< 30 Yrs or \> 75 yrs * Pregnancy (suspected or ascertained) * LV Dysfunction (LVEF \< 35% by Echo or other method) * Low (\< =20%) or high (\>=90%) probability of CAD * Acute Coronary Syndrome * Prolonged (\> 20 minutes) chest pain * De novo or accelerated angina * Hemodynamic or electrical instability * Recent ST-T segment or T wave changes of ischemic nature * Acute myocardial infarction with or without ST segment elevation * Elevated serum cardiac markers of necrosis * Known diagnosis of CAD * Previously known myocardial infarction * Previous PCI * Previous CABG * Persistent atrial fibrillation or advanced AV Block * Asthma or chronic treatment with aminophylline * Recent (\<6 months) cerebral ischemic attack * Known significant carotid stenosis or vascular aneurisms * Asthma or chronic treatment with aminophylline * Active cancer * Severe hypertension. Patients cannot withdraw therapy for 12 hours. * Congenital heart disease * Significant valvular disease * Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis) * Inability to provide an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement | 3 months from enrollment | The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-benefit and Cost-effectiveness Analysis | 3 months | Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point. |
Countries
Finland, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CTCA and PET or SPECT and ECHO or MRI | 475 |
| Total | 475 |
Baseline characteristics
| Characteristic | CTCA and PET or SPECT and ECHO or MRI |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 9 |
| Region of Enrollment Finland | 71 participants |
| Region of Enrollment France | 28 participants |
| Region of Enrollment Germany | 35 participants |
| Region of Enrollment Italy | 150 participants |
| Region of Enrollment Poland | 36 participants |
| Region of Enrollment Spain | 61 participants |
| Region of Enrollment Switzerland | 67 participants |
| Region of Enrollment United Kingdom | 27 participants |
| Sex/Gender, Customized Female | 184 participants |
| Sex/Gender, Customized Male | 291 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 475 |
| serious Total, serious adverse events | 0 / 475 |
Outcome results
Primary
Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement
The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).
Time frame: 3 months from enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non Invasive Cardiac Imaging | Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement | 140 participants |
Secondary
Cost-benefit and Cost-effectiveness Analysis
Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.
Time frame: 3 months