NCT02863939

Brief Summary

The aim of this study is to test for an early post-stress cardiac output (CO) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

July 24, 2016

Last Update Submit

August 10, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Ischemia

    Inducible and reversible perfusion defects, representing myocardial ischemia

    15-20 minutes after stress test

  • Cardiac Output

    Noninvasive evaluation of cardiac output using a novel algorithm based on impedenace

    15-20 minutes after exercise test

Study Arms (1)

NICAS

OTHER

There is only one arm - a single cohort. All patients undergoing the nuclear stress test will also have the NICAS evaluation.

Device: Single photon emission computed tomography myocardial perfusion imagingOther: exercise

Interventions

Single photon emission computed tomography myocardial perfusion imagingDEVICE

a novel cadmium-zinc-telluride (CZT) SPECT camera

NICAS
exerciseOTHER
NICAS

Eligibility Criteria

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

You may qualify if:

  • Patients referred to the Nuclear Cardiology Center for a clinically indicated exercise stress MPI study

You may not qualify if:

  • known standard contraindications for ergometry
  • anemia
  • hyperthyroidism
  • intra- and extra-cardiac shunts
  • significant arrhythmia
  • hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ronen Goldkorn, MD

CONTACT

97235302109ronen.goldkorn@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

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 11, 2016

Record last verified: 2016-08