Successful research requires teamwork

Hershey team's cooperative effort speeds clinical trial

Successful research often requires a combination of resources and cooperation that can be challenging to coordinate.

Case in point: Penn State Health Milton S. Hershey Medical Center’s participation in a clinical trial studying the safety of MRI use in patients who are implanted with a specific brand of defibrillator and lead -- a study that brings together faculty in the Penn State Heart and Vascular Institute and the hospitals’ Department of Radiology .

The Medical Center was approached to participate in the study by device manufacturer St. Jude Medical because it has patients already implanted with the devices.

“The devices are market-approved by the FDA, but St. Jude Medical wants to test whether they can be labeled as compatible with MRI,” said Katie Loffredo, lead clinical research coordinator of the study.

Hershey is the first of 60 centers participating that was able to enroll a patient in the United States and has since added a second patient.

The successful enrollment at Hershey is a credit to the cooperative effort between the Penn State Heart and Vascular Institute and the Department of Radiology, say all those involved.

“A lot of times different departments work together for clinical conditions, like testing a new drug, but in this instance we are doing a test strictly for research and for knowledge for the future,” said Dena Jefferson, a clinical research coordinator who is working on the study.  “That our physicians are willing to work together for better understanding of devices and conditions really says something.”

Agreed Loffredo, “It speaks to the atmosphere at Milton S. Hershey Medical Center; the fact that there was a willingness to work on something over and above routine care especially when our doctors are already so busy caring for their patients. We are very appreciative of that.”

Both say they have worked on studies at other places where a doctor willing to participate had to secure the permission of a hospital or another entity to move forward. At Hershey, the doctor managing the patients’ devices and the radiologist are under the same roof and willing to work together, which really streamlines the process, they said. It’s one of the advantages of being an academic health center.

“There is a growing collaboration between cardiology and radiology because they share many of the same imaging tools,” said Dr. Soraya Samii, electrophysiologist and lead clinical trial physician. “We would not have had success in this trial without cooperation from both sides.”

Dr. Nabeel Sarwani, medical director of MRI in the Department of Radiology, said it was an easy decision to partner on the study.

“Ensuring the safety of patients as well as meeting their expectations, combined with the ever increasing reliance on medical imaging by physicians were all strong motivators to partner in the study,” Sarwani said, “Once approached by Dr. Samii with the project, we realized that Radiology was key to making this project work and got to work to make it happen.”

The study is important because of the growing use of MRI.

“Since patients who are implanted with these devices are of varying ages and may develop another medical condition in their life for which they may need an MRI, it’s important to test, since these devices are made of metal – and metal and MRI don’t usually go together,” Jefferson said.

“Over the last 10 years, multiple specialties are relying more and more on MRI to make diagnoses because the resolution is outstanding,” Samii said. “It’s amazing how much MRI use has grown in these specialties.”

In the past, Samii has had to tell patients that the one restriction of getting a pacemaker or defibrillator is that they likely will not be able to get an MRI.

“It was an easy decision for patients because the life-saving or symptom-improving device outweighed any need of MRI as a diagnostic tool in the future,” she said.

If the results of this research trial go as Samii expects, patients won’t have to make a choice in the future; they will be able to have the best of both worlds.

The two patients in the study underwent MRI while closely monitored by Samii, with safety precautions in place in the event of an adverse reaction. The patients continue to be monitored for arrhythmias or any other unusual reactions.

Even if the devices are labeled safe for MRI by the FDA, patients with implantable “MRI approved” devices will still need to coordinate scheduling with device specialists for MRI compatible programming, she said.

The study is still enrolling patients with qualifying devices by invitation.


Last Updated August 30, 2016