Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion Imaging

NCT02628002 | Completed DMC

• 1 other identifier: 2014-5363
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

antigravity treadmill; bruce protocol; stress myocardial perfusion imaging; single photon emission computed tomography; cardiac catheterization; [E01.370.370.380.500]; [E01.370.370.380.250]; [E01.370.370.380.140]

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Safely Reach Target Heart Rate on the Anti-Gravity Treadmill

  Patients who are unable to perform conventional treadmill exercise will be exercised to target heart rate on the anti-gravity treadmill for stress nuclear myocardial perfusion imaging.

  1 year

Secondary Outcomes (3)

• Effect of Anti-Gravity Treadmill Exercise on Heart Rate

  1 year

• Effect of Anti-Gravity Treadmill Exercise on Blood Pressure

  1 year

• Perfusion Imaging Quality After Anti-Gravity Treadmill Exercise

  1 year

Study Arms (2)

Test arm

EXPERIMENTAL

The subjects randomized to the anti-gravity treadmill arm will be instructed on the safe use of the Alter-G treadmill by the study staff. After this instruction, subjects will be exercised on the Alter-G anti-gravity treadmill using the conventional Bruce protocol with unweighting to 75% of their body weight to reach target heart rate. If the subject is unable to reach the target heart rate, they will be further unweighted to 50% of their body weight to enable the subject to reach target heart rate on the Bruce protocol. If the subject is still unable to reach target heart rate with 50% unweighting, the patient's subsequent SPECT images will be excluded from use in the research comparison to control subject images.

Device: Antigravity treadmill (Alter-G)

Control arm

ACTIVE COMPARATOR

The control arm subjects will undergo the conventional treadmill/regadenoson pharmacological stress SPECT. Consistent with standard practice, these patients will perform adjunctive low-intensity walk on a conventional treadmill prior to regadenoson and Tc-99m injection if tolerated.

Device: Conventional treadmill/regadenoson

Interventions

Antigravity treadmill (Alter-G) DEVICE

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.

Test arm

Conventional treadmill/regadenoson DEVICE

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years of age who are able to ambulate.
• Women will either have a negative pregnancy test, be post-menopausal or have prior surgical infertility
• Nuclear stress SPECT imaging test ordered as exercise SPECT or regadenoson SPECT.
• If ordered for exercise SPECT, self-admission of inability to exercise on conventional treadmill. This typically includes subjects unable to exercise due to obesity, musculoskeletal disease, peripheral vascular disease, weakness or debilitation.
• Patients that initially start conventional treadmill exercise protocol and have to stop due to exercise-limiting symptoms including musculoskeletal pain and fatigue.
• Hemodynamically stable patients as defined by mean blood pressure (BP) \>75 mm Hg and heart rate (HR) 60-120 beats per minute.

You may not qualify if:

• Hemodynamically unstable patients as defined by resting mean BP \<75 and HR \<60 or \>120.
• Patients with acute coronary syndrome as defined by troponin elevation (\>0.05) within the past 72 hours.
• Patients at high clinical risk related to severe aortic stenosis, known exercise-induced ventricular tachycardia or fibrillation, or advanced (second-degree type II or third-degree) heart block.
• Patients with left bundle branch block or paced cardiac rhythm (in whom exercise is associated with non-ischemic perfusion abnormalities).
• Patients unable to provide consent or unable to cooperate.
• Inability to physically enter onto the anti-gravity treadmill unit.
• Pregnant women.
• Patients with a contraindication to receive regadenoson (sinus node dysfunction, high-degree heart block, active wheezing/reactive airway disease).
• At risk patient populations (prisoners or severely mentally handicapped).

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Myron Gerson, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Patrick Daly, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor emeritus of Cardiology

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)