Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01130896
• Collaborator: (none)
• Enrollment: 1,509
• Location: 1
• Actual Duration (Months): 140.7
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1509 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
• Actual Study Start Date: May 1, 2003
• Actual Primary Completion Date: Jan 22, 2015
• Actual Study Completion Date: Jan 22, 2015

Arms and Interventions

Arm	Intervention/Treatment
MRI and Cardiac Devices Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

Outcome Measures

Primary Outcome Measures

1. Device Malfunction [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

2. Patient Safety [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)

Secondary Outcome Measures

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

   We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pacemaker dependent patients with ICD's

• Patients with other contraindication to MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital, Blalcok 5 MRI	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Henry R. Halperin, M.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• PubMed Citation #1
• PubMed Citation #2

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01130896
• Other Study ID Numbers: RPN03-08-12-11
• First Posted: May 26, 2010
• Last Update Posted: May 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Johns Hopkins University: MRI, pacemakers, Defibrillator
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

Participant Flow

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and implantable cardioverter-defibrillator (ICD)
Period Title: Overall Study
STARTED	1509
COMPLETED	1509
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Overall Participants	1509
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	69.3
Sex: Female, Male (Count of Participants)
Female	548 36.3%
Male	961 63.7%
Region of Enrollment (participants) [Number]
United States	1509 100%

Outcome Measures

1. Primary Outcome

Title	Device Malfunction
Description	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
Time Frame	immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Measure Participants	1509
immediately post MRI (up to 2 hours)	24 1.6%
Long-term follow-up (up to 6 months)	52 3.4%

2. Primary Outcome

Title	Patient Safety
Description	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)
Time Frame	assessed during MRI and immediate post MRI (up to 2 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Measure Participants	1509
Count of Participants [Participants]	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Measure Participants	1509
Count of Participants [Participants]	0 0%

Adverse Events

Arm/Group Title	MRI and Cardiac Devices
Arm/Group Description	Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
All Cause Mortality
	MRI and Cardiac Devices
	Affected / at Risk (%)	# Events
Total	0/1509 (0%)
Serious Adverse Events
	MRI and Cardiac Devices
	Affected / at Risk (%)	# Events
Total	0/1509 (0%)
Other (Not Including Serious) Adverse Events
	MRI and Cardiac Devices
	Affected / at Risk (%)	# Events
Total	8/1509 (0.5%)
Surgical and medical procedures
Power on reset	8/1509 (0.5%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.