Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT

NCT ID: NCT02844686

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiac Dynamic SPECT

Group Type: EXPERIMENTAL

Cardiac SPECT

Intervention Type: OTHER

3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress

Interventions

Cardiac SPECT

3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Manrique, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Central Contacts

Alain Manrique, MD, PhD

Role: CONTACT

manrique@cyceron.fr

(+33) 231 470 287

Denis Agostini, MD, PhD

Role: CONTACT

agostini-de@chu-caen.fr

(+33) 231 063 246

Other Identifiers

2016-000119-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16-004

Identifier Type: -

Identifier Source: org_study_id