Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01239446
Status:
UNKNOWN
Last Update Posted:
2010-11-11
First Post:
2010-11-10
Brief Title:
Hybrid SPECTCTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Hybrid Single-Photon Emission Computed TomographyComputed Tomography Coronary Angiography for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients After Mediastinal Irradiation for Hodgkin Lymphoma
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
NOT_YET_RECRUITING
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:
Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery disease CAD while diabetes mellitus or other known risk factors can be absent at the time of the first coronary event Radiation-induced atherosclerosis affects the coronary ostia and proximal coronary segments or causes diffuse microvascular damage Younger patients and those exposed to high radiation doses 35 Gy have a higher risk for developing premature CAD and likely may benefit from coronary assessment
A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA
The aim of the study is to perform hybrid SPECTCTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions
A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA
The aim of the study is to perform hybrid SPECTCTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions
Detailed Description:
None
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