NCT02863952

Brief Summary

The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable coronary-artery-disease

Status
unknown

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 24, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

July 24, 2016

Last Update Submit

August 10, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • ischemia by SPECT

    severity of inducible / reversible perfusion abnormalities

    15-30 minutes post stress

Study Arms (1)

EARLY POST-STRESS EF CHANGE

OTHER

There is only a single arm. All patients undergoing the routine myocardial perfusion SPECT study will also have additional (earlier) image acquisition in order to assess the relation of early wall motion abnormalities to the severity of myocardial ischemia.

Other: Single photon emission computed tomography myocardial perfusion imagingDevice: novel cadmium-zinc-telluride (CZT) SPECT cameras

Interventions

Single photon emission computed tomography myocardial perfusion imagingOTHER
EARLY POST-STRESS EF CHANGE
novel cadmium-zinc-telluride (CZT) SPECT camerasDEVICE
EARLY POST-STRESS EF CHANGE

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • severe aortic stenosis
  • resting heart rate \> 130 beats/min
  • significant atrial or ventricular arrhythmia
  • sepsis
  • fever
  • hemodialysis
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Yafim Brodov, MD

CONTACT

+972526667119yafim.brodov@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 11, 2016

Record last verified: 2016-08