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Vasodilator

Regadenoson Stress Echo for Ischemia

Phase 4
Waitlist Available
Led By Nicolas L Palaskas, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will compare two methods of detecting coronary artery disease, nuclear stress testing with regadenoson and echocardiography strain measurements.

Who is the study for?
Adults aged 18-80 needing stress testing for pre-op evaluation of intermediate-risk cancer surgeries or with symptoms suggesting coronary disease. Eligible if they've recovered from previous heart dysfunction (LVEF of 50%+ for at least 6 months). Not eligible if they have poor ultrasound imaging quality, certain heart rhythm issues, allergy to regadenoson, a pacemaker, or high resting heart rate.Check my eligibility
What is being tested?
The study is comparing the effectiveness of regadenoson-induced stress tests using nuclear imaging and echocardiography strain measurements to detect coronary artery disease in patients undergoing specific surgical evaluations or presenting with cardiac symptoms.See study design
What are the potential side effects?
Regadenoson may cause side effects like shortness of breath, chest pain, headache, dizziness, nausea, flushing or feeling hot. It can also affect heart rhythms and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific heart stress test using regadenoson.
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I need a stress test either before a major cancer surgery or because of heart-related symptoms.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia
Secondary outcome measures
Cardiac Event Rates After ReSTE and SPECT Imaging

Trial Design

2Treatment groups
Experimental Treatment
Group I: SPECT Cardiac ImagingExperimental Treatment1 Intervention
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.
Group II: ReSTE Cardiac ImagingExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regadenoson
2012
Completed Phase 4
~5300

Find a Location

Who is running the clinical trial?

Astellas Scientific & Medical Affairs, Inc.Industry Sponsor
5 Previous Clinical Trials
1,709 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,502 Total Patients Enrolled
Nicolas L Palaskas, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Regadenoson (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT02130453 — Phase 4
Ischemia Research Study Groups: ReSTE Cardiac Imaging, SPECT Cardiac Imaging
Ischemia Clinical Trial 2023: Regadenoson Highlights & Side Effects. Trial Name: NCT02130453 — Phase 4
Regadenoson (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02130453 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study enroll minors or is there an age limitation?

"According to the eligibility requirements, individuals aged 18-80 can apply for this clinical trial. Furthermore, there are 33 studies specifically geared towards minors and 382 projects meant for elderly patients."

Answered by AI

How many participants has this clinical experiment attracted?

"At present, this trial is not actively recruiting. It was originally posted on August 1st 2014 and the latest update occurred in mid-August 2022. Currently there are 405 studies looking for patients with Ischemia and 7 more seeking participants for Regadenoson treatment trials."

Answered by AI

Are there any other scientific investigations that have been conducted involving Regadenoson?

"Currently, 7 clinical trials examining the effects of Regadenoson are underway with none reaching Phase 3. Most of these studies take place in Houston but there are also 20 other sites across the country running related experiments."

Answered by AI

Could you please assess the potential perils associated with Regadenoson use?

"Data from prior studies has deemed Regadenoson safe, thus it is assigned a score of 3 on our scale. This drug is approved for clinical use as this trial has reached Phase 4 status."

Answered by AI

Has a similar experiment been attempted before this one?

"To date, there have been 7 clinical trials conducted on Regadenoson in 12 cities across 6 countries. The inaugural trial took place in 2014, sponsored by Astellas Scientific & Medical Affairs, Inc., and included 300 participants who completed Phase 4 drug approval stage. In the ensuing years, a further 40 studies were concluded successfully."

Answered by AI

Is this investigation currently accepting new participants?

"This research effort is not currently recruiting. It was initially posted on August 1st 2014 and recently updated on the 18th of August 2022. If you are searching for other trials, 405 studies involving ischemia and 7 concerning regadenoson presently require patient volunteers."

Answered by AI

Are there any particular characteristics of participants that are desirable for this medical experiment?

"This study is enrolling 300 individuals aged between 18 and 80 who have experienced ischemia. Patients must also satisfy the following conditions: they are undergoing surgery with an intermediate risk or display symptoms potentially caused by coronary disease, possess a recent left ventricular ejection fraction of at least 50%, and be taking appropriate cardiac medication if applicable."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking
2014. "Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02130453.
~10 spots leftby Aug 2024
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