Arrhythmias, CardiacNCT01130896

Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

An observational study of Arrhythmias, Cardiac, run by Johns Hopkins University at 1 site in United States.

Completed

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

Trial summary

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol. Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Arrhythmias, Cardiac
How many people: 1,509 participants
Where: 1 siteUnited States
Study dates: May 2003to 22 Jan 2015
Phase: Observational
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 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with Implanted Cardiac Rhythm Management Devices

Who may be able to join

Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's

Who cannot join

Pacemaker dependent patients with ICD's
Patients with other contraindication to MRI

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital, Blalcok 5 MRI
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Read the detailed description

This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.

Conditions: Arrhythmias, Cardiac
Keywords: MRI, pacemakers, Defibrillator
Medical subject headings: Arrhythmias, Cardiac

What participants receive

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

Study groups in NCT01130896
Study group	Role	What they receive
MRI and Cardiac Devices		Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

What is being measured

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

Device Malfunction
Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline
Measured: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
Patient Safety
Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)
Measured: assessed during MRI and immediate post MRI (up to 2 hours)

Secondary outcomes (1)

Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance
We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images
Measured: Immediately post MRI (up to 2 hours)

Timeline

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

May 200322 Jan 2015

First posted26 May 2010 (estimated)
Study startMay 2003
Primary completion22 Jan 2015
Study completion22 Jan 2015

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01130896
Sponsor's protocol ID: RPN03-08-12-11
Status last verified: Apr 2021
First submitted: 20 May 2010
Last updated: 13 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.
PubMed 29281579
Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.
PubMed 21969340
Ra J, Oberdier MT, Suzuki M, Vaidya D, Liu Y, Hansford R, McVeigh D, Weltin V, Tao S, Thiemann DR, Nazarian S, Halperin HR. Implantable Defibrillator System Shock Function, Mortality, and Cause of Death After Magnetic Resonance Imaging. Ann Intern Med. 2023 Mar;176(3):289-297. doi: 10.7326/M22-2653. Epub 2023 Jan 31.
PubMed 36716451
Rahsepar AA, Zimmerman SL, Hansford R, Guttman MA, Castro V, McVeigh D, Kirsch JE, Halperin HR, Nazarian S. The Relationship between MRI Radiofrequency Energy and Function of Nonconditional Implanted Cardiac Devices: A Prospective Evaluation. Radiology. 2020 May;295(2):307-313. doi: 10.1148/radiol.2020191132. Epub 2020 Mar 3.
PubMed 32125255

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?

See locations

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Paroxysmal AF
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
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All Arrhythmias, Cardiac trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
ClinicalTrials.gov ID: NCT01130896
Acronym / sponsor ID: RPN03-08-12-11
Conditions: Arrhythmias, Cardiac
Keywords: MRI, pacemakers, Defibrillator
Study type: Observational
Recruitment status: Completed
Enrolment: 1,509 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: May 2003 (actual)
Primary completion: 22 Jan 2015 (actual)
Study completion: 22 Jan 2015 (actual)
First posted: 26 May 2010 (estimated)
Results: Posted 12 Dec 2018

Clinical summary

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

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
MRI and Cardiac Devices	–	–Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with Implanted Cardiac Rhythm Management Devices

Key inclusion criteria (1 listed)

Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's

Key exclusion criteria (2 listed)

Pacemaker dependent patients with ICD's
Patients with other contraindication to MRI

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

Primary outcome

Device Malfunction
Time frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline
Patient Safety
Time frame: assessed during MRI and immediate post MRI (up to 2 hours)
Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)

1 secondary outcome

Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance
Time frame: Immediately post MRI (up to 2 hours)

Results and safety

Results posted to the registry on 12 Dec 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
MRI and Cardiac Devices	1,509	1,509

Primary outcome: Device Malfunction

Time frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months). Count of participants. Unit: Participants

Measure	MRI and Cardiac Devices n = 1509
immediately post MRI (up to 2 hours)	24
Long-term follow-up (up to 6 months)	52

Primary outcome: Patient Safety

Time frame: assessed during MRI and immediate post MRI (up to 2 hours). Count of participants. Unit: Participants

Measure	MRI and Cardiac Devices n = 1509
Value	0

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI and Cardiac Devices	0 of 1,509 (0%)	8 of 1,509 (0.5%)	0 of 1,509

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29281579Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.
Results publication: PubMed 21969340Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.
Derived from this study: PubMed 36716451Ra J, Oberdier MT, Suzuki M, Vaidya D, Liu Y, Hansford R, McVeigh D, Weltin V, Tao S, Thiemann DR, Nazarian S, Halperin HR. Implantable Defibrillator System Shock Function, Mortality, and Cause of Death After Magnetic Resonance Imaging. Ann Intern Med. 2023 Mar;176(3):289-297. doi: 10.7326/M22-2653. Epub 2023 Jan 31.
Derived from this study: PubMed 32125255Rahsepar AA, Zimmerman SL, Hansford R, Guttman MA, Castro V, McVeigh D, Kirsch JE, Halperin HR, Nazarian S. The Relationship between MRI Radiofrequency Energy and Function of Nonconditional Implanted Cardiac Devices: A Prospective Evaluation. Radiology. 2020 May;295(2):307-313. doi: 10.1148/radiol.2020191132. Epub 2020 Mar 3.
PubMed Citation #1Link provided by the sponsor.
PubMed Citation #2Link provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Arrhythmias, Cardiac

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

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.

Henry R. Halperin, M.D. principal investigator

Johns Hopkins University

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

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmias, Cardiac, run by Johns Hopkins University 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 1 inclusion and 2 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 13 May 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 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?

Device Malfunction (time frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)). 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 NCT01130896, which also lists 4 linked publications.

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 13 May 2021.