Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking

NCT02130453 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2013-0881NCI-2014-01162
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare regadenoson nuclear stress testing with echocardiography strain measurements (an ultrasound imaging method that measures hearts function) in detecting coronary artery disease.

Conditions

Ischemia

Keywords

Ischemia; Coronary artery disease; Nuclear stress test; Stress Echocardiogram; Echocardiography strain measurement; Ultrasound cardiac imaging; ReSTE; SPECT; Regadenoson

Outcome Measures

Primary Outcomes (1)

• Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia

  As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.

  1 day

Secondary Outcomes (1)

• Cardiac Event Rates After ReSTE and SPECT Imaging

  30 days

Study Arms (2)

ReSTE Cardiac Imaging

EXPERIMENTAL

Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.

Drug: Regadenoson

SPECT Cardiac Imaging

OTHER

After resting strain measurement done, first set of nuclear images taken. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving Regadenoson, measurements repeated. These measurements take about 2 minutes to complete. At about 30 minutes after Regadenoson given, participant will have final images for the nuclear portion of the testing.

Drug: Regadenoson

Interventions

Regadenoson DRUG

0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.

ReSTE Cardiac Imaging; SPECT Cardiac Imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent.
• Indications for stress testing is either: -as part of a pre-operative evaluation prior to a planned cancer related surgery that is considered to be at least of intermediate risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate surgery) OR -as an evaluation in the cardiology clinic for symptoms described in a cardiology consult as typical angina, or of significant suspicion for coronary disease or symptoms described as likely of a cardiac/coronary etiology.
• Patients with a history of LV dysfunction will be still candidates for enrollment in the study if they have documented LVEF recovery (most recent documented LVEF of 50% or higher) for at least 6 months prior to SPECT regardless of current cardiac medication regimen.
• Age 18 - 80 years.

You may not qualify if:

• Patients consented for the trial that on the baseline 2D study have poor acoustic echo windows (i.e. a reader is unable to see in definition 2 or more segments from the apical views) will not be eligible to continue in the trial and peak hyperemia images will not be obtained.
• Any patient with tachycardia defined as HR of 100 or higher at the day of SPECT will not be eligible for this study.
• Second- or third- degree AV block.
• Sinus node dysfunction.
• Patients with allergy to regadenoson.
• Patients with LBBB and/or artificial pacemaker.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Astellas Scientific & Medical Affairs, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Ischemia; Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Nicolas Palaskas, MD
• Organization: The University of Texas MD Anderson Cancer Center

nlpalaskas@mdanderson.org

(713) 745-1942

Study Officials

• Nicolas L Palaskas, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: September 30, 2014
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-07

Locations

US (1)