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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK119740-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS and venography group | Experimental | Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venography | Diagnostic Test | The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of stenosis | The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA. | 18 months |
| Length of lesions | The length of each lesion will be measured between points with >50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment. | 18 months |
| Morphology of lesion | The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vipul Chitalia, MD PhD | Contact | 617 638 7330 | vipul.chitalia@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Vipul Chitalia, MD PhD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D010690 | Phlebography |
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D000792 | Angiography |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| Intravascular ultrasound (IVUS) | Diagnostic Test | IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter. |
|
| Image processing | Other | Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy. |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D003933 |
| Diagnosis |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D014463 | Ultrasonography |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |