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NCT00631904 · ClinicalTrials.gov registry record
St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study
A clinical trial of Cardiovascular Disease, sponsored by Essentia Health.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT00631904 is a study of Cardiovascular Disease that has completed, run by Essentia Health. The registered enrollment target is 150 participants, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00631904, a study of Cardiovascular Disease, has completed, sponsored by Essentia Health.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans. Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions. Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published. Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear. This study will evaluate patients with permanent pacemakers undergoing medically indicated MRI scanning. Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the MRI scan.
Conditions Studied
Study Locations (1)
Minnesota
- Essentia Health - Duluth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00631904
The ClinicalTrials.gov registry entry for NCT00631904 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (94% lower). The listed sponsor is Essentia Health, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 0 interventions.
NCT00631904 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT00631904 about?
NCT00631904 is a clinical study titled "St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study". The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans. Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging o...
What is the current status of trial NCT00631904?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2005-01. Estimated completion is 2011-07.
What conditions does trial NCT00631904 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
Who is sponsoring clinical trial NCT00631904?
This trial is sponsored by Essentia Health, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00631904 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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