Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01899833
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2013-07-10
Brief Title:
Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease CAD
Sponsor:
CellPoint LLC
Organization:
CellPoint LLC
Study Overview
Official Title:
A Prospective Open-label Multicenter Study With Blinded Over-reading Characterizing the Efficacy and Safety of 99mTc-EC-DG in the Evaluation of Coronary Artery Disease CAD
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_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:
This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease radiolabeled Sestamibi during a rest and stress cardiac test as documented from results of a coronary angiogram if performed
Detailed Description:
This study will be a prospective open-label multi-center study assessing the efficacy and safety of 99mTc-EC-DG compared to 99mTc-SPECT MPI imaging for detecting the presence location and severity of CAD as established by coronary angiography Approximately 60 patients will be enrolled in the study
Group 1 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method nuclear ultrasound CTA MRI etc and their physician has planned for coronary angiography but angiography has not yet been performed In addition the patient has not had coronary artery bypass graft CABG These patients can be enrolled
Group 2 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method nuclear ultrasound CTA MRI etc and the patient has already had coronary angiography performed but has not received any coronary intervention subsequent to the procedure
The following sequence of imaging procedures will be performed for both Group 1 and 2 patients The first procedure will be a 99mTc-EC-DG rest study This will be followed within 24 hours to 3 days with a 1-day protocol 99mTc-SPECT MPI reststress study This will be followed within 24 hours to 3 days with a 99mTc-EC-DG stress study
For both Group 1 and 2 if 1 of the diagnostic imaging procedures performed to evaluate the presence of CAD was a traditional 99mTc-SPECT MPI reststress study this procedure must be repeated as 1 of the 3 SPECT imaging procedures required by the trial protocol
The modality for provocative stress testing exercise pharmacologic or exercisepharmacologic will be matched between the 99mTc-SPECT study and the 99mTc-EC-DG study All prospectively performed 99mTc-EC-DG and 99mTc-SPECT studies will be conducted using regadenoson as the pharmacologic stress agent All imaging studies 99mTc-EC-DG 99mTc-SPECT coronary angiography will be over-read by blinded trained reviewers The consensus blinded read will determine and record the location of the CAD by relating the wall of the myocardium affected to include anterior Inferior lateral septal and apex The angiography study will identify the arteries associated with the CAD namely left anterior descending circumflex or right coronary arteries The study will also determine the severity of the CAD by visually comparing the size and intensity of the ischemic signal on rest and stress images obtained approximately 15 and 60 minutes post injection
The results from the consensus blinded read of coronary angiography will be considered truth for the presence location and severity of obstructive CAD and degree of stenosis
Group 1 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method nuclear ultrasound CTA MRI etc and their physician has planned for coronary angiography but angiography has not yet been performed In addition the patient has not had coronary artery bypass graft CABG These patients can be enrolled
Group 2 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method nuclear ultrasound CTA MRI etc and the patient has already had coronary angiography performed but has not received any coronary intervention subsequent to the procedure
The following sequence of imaging procedures will be performed for both Group 1 and 2 patients The first procedure will be a 99mTc-EC-DG rest study This will be followed within 24 hours to 3 days with a 1-day protocol 99mTc-SPECT MPI reststress study This will be followed within 24 hours to 3 days with a 99mTc-EC-DG stress study
For both Group 1 and 2 if 1 of the diagnostic imaging procedures performed to evaluate the presence of CAD was a traditional 99mTc-SPECT MPI reststress study this procedure must be repeated as 1 of the 3 SPECT imaging procedures required by the trial protocol
The modality for provocative stress testing exercise pharmacologic or exercisepharmacologic will be matched between the 99mTc-SPECT study and the 99mTc-EC-DG study All prospectively performed 99mTc-EC-DG and 99mTc-SPECT studies will be conducted using regadenoson as the pharmacologic stress agent All imaging studies 99mTc-EC-DG 99mTc-SPECT coronary angiography will be over-read by blinded trained reviewers The consensus blinded read will determine and record the location of the CAD by relating the wall of the myocardium affected to include anterior Inferior lateral septal and apex The angiography study will identify the arteries associated with the CAD namely left anterior descending circumflex or right coronary arteries The study will also determine the severity of the CAD by visually comparing the size and intensity of the ischemic signal on rest and stress images obtained approximately 15 and 60 minutes post injection
The results from the consensus blinded read of coronary angiography will be considered truth for the presence location and severity of obstructive CAD and degree of stenosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None