Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01122810
Status:
COMPLETED
Last Update Posted:
2011-03-09
First Post:
2010-03-02
Brief Title:
Scanner and Transplant Heart Patients Protocol
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
Head to Head Comparison of Multidetector Coronary Tomography and Conventional Coronary Angiogram in the Setting of Systematic Screening of Coronary Vasculopathy After Orthotopic Heart Transplantation
Status:
COMPLETED
Status Verified Date:
2011-03
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:
None
Brief Summary:
Coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation It is mainly asymptomatic because of the denervation of the heart transplant Currently annual invasive coronary angiogram is performed to ensure the lack of coronary narrowing But invasive coronary angiography caries risks of serious adverse events and some concern rise from its repetition in that population Recent advance in coronary multidetector computed tomography CT may allow non invasive visualization of the coronary tree But it remains unknown if the encouraging data observed in native coronary artery analysis can be extrapolated to transplant heart recipients Indeed only very small sample size studies 20 patients have been conducted in this particular setting Thus the investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT compared to the gold standard coronary angiogram in a larger sample size study The practice aim of this study is to determine if the conventional invasive coronarography can be switched by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient without any coronary artery disease CAD or those with CAD not suitable for percutaneous coronary intervention
Detailed Description:
Background
Heart transplantation is a major advance in the care of patient with terminal heart failure But despite the spectacular prognosis improvement obtained with this treatment coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation 8 of death at 1 year 42 at 5 years This coronary artery disease CAD has a particular feature involving immunological and inflammatory process also favoured by classical risk factors in the context of immunosuppression with rapid and diffuse involvement Because of the denervation of the transplant heart it remains mainly asymptomatic and let non invasive stress tests with poor accuracy for CAD screening It explains the current use of systematic coronary angiogram to transplant heart recipients survey
But coronary angiogram remains an invasive technique and exposed to potential serious adverse events
The recent advance in coronary multidetector computed tomography CT may allow non invasive visualization of the coronary tree Indeed 64-row CT has already showed its accuracy for the screening of CAD in symptomatic patient in sinus rhythm However they are very few studies in the setting of heart transplantation with small sample size and mainly using 16-row CT Only two small sample size studies 20 patients each have been conducted using 64-row CT in the setting of heart transplant recipients None of them compared X-Ray and contrast iodine exposure
Aim
Our primary aim is to compare the diagnostic accuracy value of the 64-row CT and 256-row CT to the gold standard conventional coronary angiogram in the setting of CAD screening in a large population of heart transplant recipients 110 pts We make the assumption that the sensitivity of CT is enough to allow switching the coronary angiogram by CT for the screening of asymptomatic CAD in heart transplant recipients without CAD or with CAD not suitable for revascularization
We plan also to compare X-Ray and contrast agent exposure
Methods
All the transplant heart patients systematically followed in the cardiovascular and thoracic surgery service will be prospectively included All the patients will sign the informed consent then CT will be performed 24 H before the coronary angiogram
multidetector coronary computed tomography The Electrocardiogram ECG-gated contrast-enhanced multidetector computed tomography coronary angiography will be performed with a 64 or 256-row CT Philips Brilliance The contrast medium Iomeron ioméprol Bracco-Altana Pharma GmbH mean quantity used is 80-100 ml The CT scan parameters adapted to the patients weight include 120 kV 800mA 0625 mm slice thickness 042-s rotation time and 02 pitch To determine X-Ray exposure Dose Length Product Gycm will be measured
After the scan the reconstruction will be performed at 40 and 75 of the cycle using ECG gating Additional reconstructions at different phase can be performed in case of coronary calcification or motion artefacts
A semi quantitative analyse Nnormal Iintermediate Sstenosis of coronary narrowing will be performed blindly to coronary angiogram results by two experienced radiologists The CT quality will be determined using a quality scale scale from 1 to 5
A Calcification score will also be determined A segment analyse will be performed according to AHA classification 17 segments model Only more than 15 mm diameter vessel segments will be analysed
Coronary angiogram
According to good practice patients will receive 09 saline serum intravenously at a dose of 1000 ml per 12 H before and 1000 ml per 12 H after contrast medium injection
Coronary angiogram will be performed according to standard protocol using radial access with 4 or 5 French sheath under continuous invasive survey of blood pressure and ECG monitoring The contrast medium quantity used Hexabrix sodium and méglumine ioxaglate Guerbet as the X-Ray dose era product Gycm² will be measured
Quantitative coronary analysis will be performed by two experienced interventional cardiologists blind to the CT results Significant stenosis is defined by a 50 vessel narrowing
Serum creatinine will be controlled the day before the day after and 72 H after the coronary angiogram
Statistical analysis
Comparison of the two techniques will be done by segments by artery and by patients with determination of the sensitivity specificity positive and negative predictive value of CT for the screening of significant coronary stenosis 50 Statistical analysis will be made with Statview 50
Ethical comity
All the patient receive and sign an informed consent The ethical comity CPP Ile-de-France VI approves the protocol and the French Society of Cardiology supported the study
Expected Calendar
We plan to perform the CT during systematic annual hospitalisation for invasive coronary angiogram In the cardiovascular department approximately 8 patients benefit from coronary angiogram per week Thus we plan to include 110 patients within 30 months taking in account the exclusion criteria and the availability of both techniques
Heart transplantation is a major advance in the care of patient with terminal heart failure But despite the spectacular prognosis improvement obtained with this treatment coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation 8 of death at 1 year 42 at 5 years This coronary artery disease CAD has a particular feature involving immunological and inflammatory process also favoured by classical risk factors in the context of immunosuppression with rapid and diffuse involvement Because of the denervation of the transplant heart it remains mainly asymptomatic and let non invasive stress tests with poor accuracy for CAD screening It explains the current use of systematic coronary angiogram to transplant heart recipients survey
But coronary angiogram remains an invasive technique and exposed to potential serious adverse events
The recent advance in coronary multidetector computed tomography CT may allow non invasive visualization of the coronary tree Indeed 64-row CT has already showed its accuracy for the screening of CAD in symptomatic patient in sinus rhythm However they are very few studies in the setting of heart transplantation with small sample size and mainly using 16-row CT Only two small sample size studies 20 patients each have been conducted using 64-row CT in the setting of heart transplant recipients None of them compared X-Ray and contrast iodine exposure
Aim
Our primary aim is to compare the diagnostic accuracy value of the 64-row CT and 256-row CT to the gold standard conventional coronary angiogram in the setting of CAD screening in a large population of heart transplant recipients 110 pts We make the assumption that the sensitivity of CT is enough to allow switching the coronary angiogram by CT for the screening of asymptomatic CAD in heart transplant recipients without CAD or with CAD not suitable for revascularization
We plan also to compare X-Ray and contrast agent exposure
Methods
All the transplant heart patients systematically followed in the cardiovascular and thoracic surgery service will be prospectively included All the patients will sign the informed consent then CT will be performed 24 H before the coronary angiogram
multidetector coronary computed tomography The Electrocardiogram ECG-gated contrast-enhanced multidetector computed tomography coronary angiography will be performed with a 64 or 256-row CT Philips Brilliance The contrast medium Iomeron ioméprol Bracco-Altana Pharma GmbH mean quantity used is 80-100 ml The CT scan parameters adapted to the patients weight include 120 kV 800mA 0625 mm slice thickness 042-s rotation time and 02 pitch To determine X-Ray exposure Dose Length Product Gycm will be measured
After the scan the reconstruction will be performed at 40 and 75 of the cycle using ECG gating Additional reconstructions at different phase can be performed in case of coronary calcification or motion artefacts
A semi quantitative analyse Nnormal Iintermediate Sstenosis of coronary narrowing will be performed blindly to coronary angiogram results by two experienced radiologists The CT quality will be determined using a quality scale scale from 1 to 5
A Calcification score will also be determined A segment analyse will be performed according to AHA classification 17 segments model Only more than 15 mm diameter vessel segments will be analysed
Coronary angiogram
According to good practice patients will receive 09 saline serum intravenously at a dose of 1000 ml per 12 H before and 1000 ml per 12 H after contrast medium injection
Coronary angiogram will be performed according to standard protocol using radial access with 4 or 5 French sheath under continuous invasive survey of blood pressure and ECG monitoring The contrast medium quantity used Hexabrix sodium and méglumine ioxaglate Guerbet as the X-Ray dose era product Gycm² will be measured
Quantitative coronary analysis will be performed by two experienced interventional cardiologists blind to the CT results Significant stenosis is defined by a 50 vessel narrowing
Serum creatinine will be controlled the day before the day after and 72 H after the coronary angiogram
Statistical analysis
Comparison of the two techniques will be done by segments by artery and by patients with determination of the sensitivity specificity positive and negative predictive value of CT for the screening of significant coronary stenosis 50 Statistical analysis will be made with Statview 50
Ethical comity
All the patient receive and sign an informed consent The ethical comity CPP Ile-de-France VI approves the protocol and the French Society of Cardiology supported the study
Expected Calendar
We plan to perform the CT during systematic annual hospitalisation for invasive coronary angiogram In the cardiovascular department approximately 8 patients benefit from coronary angiogram per week Thus we plan to include 110 patients within 30 months taking in account the exclusion criteria and the availability of both techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None