Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT
Flow-Heart
Feasibility of Dynamic Cardiac SPECT With 99mTc-diethylenetriaminepenta-acetate (DTPA) for the Assessment of Myocardial Flow Reserve Using a Cadmium-Zinc-Telluride (CZT) Camera
2 other identifiers
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Aug 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 26, 2016
July 1, 2016
2 years
July 21, 2016
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA
Within one month after a conventional myocardial perfusion SPECT
Study Arms (1)
Cardiac Dynamic SPECT
EXPERIMENTALInterventions
3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Manrique, MD, PhD
University Hospital, Caen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2016
First Posted
July 26, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
July 26, 2016
Record last verified: 2016-07