Coronary Artery DiseasePhase 4NCT02115308

Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

A Phase 4 study testing Regadenoson in people with Coronary Artery Disease, run by Timothy M. Bateman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test. Read more about this study

Who is it for?: Ages 19 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease
What is being tested?: Regadenoson
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2014to 23 Mar 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Myocardial rest/regadenoson stress perfusion PET study within 60 days
Normal rest LVEF (greater than or equal to 50%)
No change in symptoms or treatment between the PET and the MRI study
Willing to consent to the study
Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.

Who cannot join

Renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73m2) within 6 months
Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
Patient size exceeds MRI bore/table limits: (Max body diameter > 60 cm, weight > 136 kg)
History of gadolinium contrast allergy or intolerance
Second or third degree AV block
Sinus node dysfunction

Show all 9Show fewer

Acute myocardial infarction (past 3 months)
Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days
Patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson

Trial locations and contacts

1 site in 1 country.

United States1 site

Saint Luke's Health System
Kansas City, Missouri, 64111

Other trials in United States

About this study

The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.

Conditions: Coronary Artery Disease
Being tested: Regadenoson
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RegadenosonDrug
Also called Lexiscan
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.

Study groups in NCT02115308
Study group	Role	What they receive
Regadenoson	Other	Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson. Receives: Drug: Regadenoson

What is being measured

The primary outcome is the main question the study is designed to answer.

RADIAL STRAIN
A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening.
Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.
Measured: Day 1
CIRCUMFERENTIAL STRAIN
A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening.
Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.
Measured: Day 1

Secondary outcomes (3)

Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain
For each subject, the 16-segments were visually assessed along the short-axis plane for the presence of LGE. These images were collected post regadenoson stress recovery using an inversion-recovery prepared, fast gradient echo sequence and a delay of at least 8 minutes after administration of a single dose of gadobenate dimeglumine.
The presence of LGE within a segment is a separate classification of segment type. The segment classifications in the other outcomes are determined from the prior positron-emission-tomography (PET) examination where the LGE determination is based solely on cardiac magnetic resonance (CMR) imaging collected data.
The measurement was performed to determine if the presence of LGE within a particular segment affect the resulting strain?
Measured: Day 1
Adverse Events
Adverse events were monitored and recorded on a specific Adverse Event (AE) log.
Measured: Day 1
Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain
The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 201423 Mar 2018

First posted16 Apr 2014 (estimated)
Study start3 Sep 2014
Primary completion16 Jan 2018
Study completion23 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02115308
Sponsor's protocol ID: Astellas CMR Tagging
Status last verified: Aug 2018
First submitted: 1 Apr 2014
Last updated: 19 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT02115308
Acronym / sponsor ID: Astellas CMR Tagging
Conditions: Coronary Artery Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Timothy M. BatemanUniversity, hospital or other
Collaborators: Saint Luke's Health System, Saint Luke's Cardiovascular Consultants
Study start: 3 Sep 2014 (actual)
Primary completion: 16 Jan 2018 (actual)
Study completion: 23 Mar 2018 (actual)
First posted: 16 Apr 2014 (estimated)
Results: Posted 19 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Regadenoson	Other	Drug: RegadenosonRegadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Myocardial rest/regadenoson stress perfusion PET study within 60 days
Normal rest LVEF (greater than or equal to 50%)
No change in symptoms or treatment between the PET and the MRI study
Willing to consent to the study
Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.

Key exclusion criteria (9 listed)

Renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73m2) within 6 months
Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
Patient size exceeds MRI bore/table limits: (Max body diameter > 60 cm, weight > 136 kg)
History of gadolinium contrast allergy or intolerance
Second or third degree AV block

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RegadenosonAlso: LexiscanRegadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.	Drug	Regadenoson

Primary outcome

RADIAL STRAIN
Time frame: Day 1
A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.
CIRCUMFERENTIAL STRAIN
Time frame: Day 1
A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.

3 secondary outcomes

Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain
Time frame: Day 1
Adverse Events
Time frame: Day 1
Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain
Time frame: Day 1

Results and safety

Results posted to the registry on 19 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CONTROL	15	13
Coronary Artery Disease	25	23

Primary outcome: RADIAL STRAIN

Time frame: Day 1. Mean (Standard Deviation). Unit: unitless (strain)

Measure	CONTROL n = 13	CAD_REMOTE n = 23	CAD_REVERSIBLE n = 23
REST	0.158 (0.100)	0.149 (0.098)	0.150 (0.094)
REGADENOSON STRESS	0.190 (0.113)	0.167 (0.104)	0.141 (0.085)
REST-to-STRESS CHANGE	0.033 (0.137)	0.022 (0.107)	-0.009 (0.099)

CONTROL: p = 0.001, paired, t-test
CAD_REMOTE: p = 0.017, paired, t-test
CAD_REVERSIBLE: p = 0.495, paired, t-test

Population analysed: Myocardial segments classified according to subject groups and myocardial perfusion and wall motion scores on prior positron-emission-tomography (PET).

Primary outcome: CIRCUMFERENTIAL STRAIN

Time frame: Day 1. Mean (Standard Deviation). Unit: strain (unitless)

Measure	CONTROL n = 13	CAD_REMOTE n = 23	CAD_REVERSIBLE n = 23
REST	-0.181 (0.056)	-0.140 (0.057)	-0.121 (0.054)
REGADENSOSON STRESS	-0.169 (0.059)	-0.150 (0.053)	-0.126 (0.066)
REST-to-STRESS CHANGE	0.012 (0.065)	-0.013 (0.051)	-0.006 (0.051)

CONTROL: p = 0.011, paired, t-test
CAD_REMOTE: p = 0.003, paired t-test
CAD_REVERSIBLE: p = 0.390, paired, t-test

Population analysed: Myocardial segments from the population groups according to the AHA 16-segment model and classified according to PET perfusion and wall motion scores.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regadenoson	0 of 36 (0%)	29 of 36 (80.6%)	0 of 36

Limitations and caveats (from the sponsor): Reported strain is not adjusted for myocardial mass.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy M Bateman, MD principal investigator

Aspire Foundation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Regadenoson in people with Coronary Artery Disease, run by Timothy M. Bateman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RADIAL STRAIN (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02115308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.