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Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion Imaging

NCT02628002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-05-09

No results posted yet for this study

Summary

This study will test the hypothesis that the anti-gravity treadmill can be safely used in stress nuclear myocardial perfusion imaging in patients unable to perform conventional treadmill exercise.

This will be foundational evidence on which to consider a larger clinical trial to show that the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT as well as having implications for cardiac PET and MRI in the future.

Conditions

Interventions

DEVICE

Antigravity treadmill (Alter-G)

Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection.

DEVICE

Conventional treadmill/regadenoson

Subjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Myron Gerson, MD · University of Cincinnati

  • Patrick Daly, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02628002 on ClinicalTrials.gov