Back to resultsMyocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT (Flow-Heart)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiac SPECT
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Myocardial perfusion imaging, Single-Photon Emission Computer-Assisted Tomography
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- Patient clinically stable with known or suspected coronary disease
- Patient referred to Caen University Hospital for a myocardial perfusion SPECT
- Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress
- Informed consent dated and signed
- Affiliation to a social security system
Exclusion Criteria:
- Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension)
- History of poor tolerance of dipyridamole injection
- Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex)
- Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator
- Recent history of myocardial infarction or unstable angina
- Pregnancy or lactating women
- Known obstructive renal or urinary disease
- Age under 18 years or guardianship
- Patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion SPECT and the subsequent 99mTc-DTPA dynamic SPECT
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac Dynamic SPECT
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02844686
Brief Title
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT
Acronym
Flow-Heart
Official Title
Feasibility of Dynamic Cardiac SPECT With 99mTc-diethylenetriaminepenta-acetate (DTPA) for the Assessment of Myocardial Flow Reserve Using a Cadmium-Zinc-Telluride (CZT) Camera
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
5. Study Description
Brief Summary
New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac SPECT in 20 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Myocardial perfusion imaging, Single-Photon Emission Computer-Assisted Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Dynamic SPECT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cardiac SPECT
Intervention Description
3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress
Primary Outcome Measure Information:
Title
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA
Time Frame
Within one month after a conventional myocardial perfusion SPECT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years
Patient clinically stable with known or suspected coronary disease
Patient referred to Caen University Hospital for a myocardial perfusion SPECT
Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress
Informed consent dated and signed
Affiliation to a social security system
Exclusion Criteria:
Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension)
History of poor tolerance of dipyridamole injection
Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex)
Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator
Recent history of myocardial infarction or unstable angina
Pregnancy or lactating women
Known obstructive renal or urinary disease
Age under 18 years or guardianship
Patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion SPECT and the subsequent 99mTc-DTPA dynamic SPECT
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Manrique, MD, PhD
Phone
(+33) 231 470 287
Email
manrique@cyceron.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Agostini, MD, PhD
Phone
(+33) 231 063 246
Email
agostini-de@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Manrique, MD, PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT
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