Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT | NCT02844686

Studies
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT

NCT02844686

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Cardiac SPECT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-000119-34	EudraCT Number

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Jul 21, 2016

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Dynamic SPECT	Experimental		Other: Cardiac SPECT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac SPECT	Other	3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress	Cardiac Dynamic SPECT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alain Manrique, MD, PhD	Contact	(+33) 231 470 287		manrique@cyceron.fr
Denis Agostini, MD, PhD	Contact	(+33) 231 063 246		agostini-de@chu-caen.fr

Overall Officials

Name	Affiliation	Role
Alain Manrique, MD, PhD	University Hospital, Caen	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided