INDIANAPOLIS – Heart attack patients and others with coronary conditions may benefit from a catheter-based pump device being evaluated in a clinical trial now under way at St. Francis Hospital & Health Centers.
The device is the Impella 2.5, developed by the Massachusetts-based Abiomed Inc. St. Francis is one of the few medical facilities to participate in the PROTECT II trial, the second Food and Drug Administration-approved trial for prophylactic preventive use of the device during non-emergent high-risk coronary intervention procedures.
“We are please to participate in the pivotal PROTECT II trial and we look forward to improving the treatment of high-risk patients,” said principal investigator William J. Berg, M.D., of the Indiana Heart Physicians and St. Francis Heart Center. “The Impella offers physicians a minimally invasive breakthrough technology in cardiac treatment and we’re excited to further demonstrate its effectiveness in this secondary trial.”
The current trial follows Abiomed’s previous PROTECT I trial, which yielded successful results for the ease-of-use and safety of the device, according to company officials.
The Impella 2.5, the world's smallest ventricular assist device (VAD), provides patients with up to 2.5 liters of blood flow per minute. It’s been used to treat more than 1,000 patients in Europe who have had heart attacks and cardiogenic shock, a condition in which a weakened heart cannot pump enough blood to meet the body’s needs.
The trial was approved earlier this year by institutional review board, which oversees all clinical investigations conducted at St. Francis Hospital & Health Centers.
To be eligible for the study, patients must have a left main lesion, only one remaining vessel open, or have triple vessel disease. They also must have a low ejection fraction (below 30 percent or 35 percent, depending on their other qualifying traits).
For more information about the trial, contact Kathy Lawson at 317-851-2582.
More details about the Abiomed’s Impella 2.5 device can be found at www.abiomed.com/products/impella.cfm.
The St. Francis Heart Center is a state-of-the-art facility and the only full-service cardiac and vascular care program on Indianapolis’ south side. For more information about its services go to www.stfrancishospitals.org/Heart.
Editors/Reporters: Still images and DVD B-roll are available
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Monday, May 19, 2008
Monday, January 21, 2008
Nurse navigators help cancer patients maneuver through treatment
INDIANAPOLIS – When first diagnosed with cancer, a person often feels set adrift in a murky sea of uncertainty and fear – and alone in their struggle.
But an innovative program at St. Francis Hospital & Health Centers helps patients from the time of diagnosis throughout their treatment regimen. It’s the nurse navigator program and it’s designed for patients and their families with colorectal and head and neck cancers.
This nurse specialist assists patients in coordinating diagnostic appointments and physician visits, along with helping to manage symptoms, providing education, increasing awareness of clinical trial availability and very importantly, easing patient anxiety.
"We augment what’s being done on the clinical side by helping guide patients through every step of the treatment and beyond," said Karen Norris, R.N., nurse navigator at St. Francis’ Colorectal Cancer Center of Excellence. "It’s not enough for the technology to be good – you have to provide the human touch to the people you serve."
Norris, who took on her role as a nurse navigator in mid-2007, is an integral player on a team of more than 25 physician specialists including gastroenterologists, colorectal surgeons, general surgeons, radiation oncologists, medical oncologists, pathologists, family practice physicians and radiologists who comprise the Center.
"It truly is a collaborative effort and our physicians and other specialists do a wonderful job in communicating and coming together to decide what’s best for patients," Norris said.
Nurse Practitioner Janice Leak’s role as St. Francis’ other nurse navigator – she was the first in 2006 – has positioned her as a key link between physicians and patients receiving care for head and neck cancers. The patients Leak works with often go through different treatment phases, often a combination of surgery, radiation and chemotherapy, and that means they will be seen by different physicians and technicians for tests and procedures.
Leak currently works with about 48 patients having head and neck-related cancers; Norris has a caseload of more than 70 patients at St. Francis hospitals in Indianapolis, Beech Grove and Mooresville.
"Cancer treatment can seem very complex and segmented to patients," Leak said. "That’s where a nurse navigator can be a common thread to help weave the patient through the process and so that they feel supported throughout the process."
Cheryl Snooks is one patient who has experienced that process. The business project manager was diagnosed with an oral-related cancer in 2006 at St. Francis and was immediately paired with Leak.
"As you go from diagnosis to treatment, your questions and concerns change," Snooks said. "It was helpful to have Janice there with the answers and to have a positive experience."
As part of the Center’s commitment to provide the newest technology and highest quality of care, Norris explained that all patients are screened for enrollment in clinical trials. These research studies are among nearly 100 now under way and overseen by the St. Francis Cancer Research Foundation.
The attention doesn’t end with treatment. Norris and Leak both follow up with their patients long after their therapies.
St. Francis also has plans to expand its nurse navigator program into lung cancer.
More information about Cancer Care Services at St. Francis is at http://stfrancishospitals.org/cancer.
But an innovative program at St. Francis Hospital & Health Centers helps patients from the time of diagnosis throughout their treatment regimen. It’s the nurse navigator program and it’s designed for patients and their families with colorectal and head and neck cancers.
This nurse specialist assists patients in coordinating diagnostic appointments and physician visits, along with helping to manage symptoms, providing education, increasing awareness of clinical trial availability and very importantly, easing patient anxiety.
"We augment what’s being done on the clinical side by helping guide patients through every step of the treatment and beyond," said Karen Norris, R.N., nurse navigator at St. Francis’ Colorectal Cancer Center of Excellence. "It’s not enough for the technology to be good – you have to provide the human touch to the people you serve."
Norris, who took on her role as a nurse navigator in mid-2007, is an integral player on a team of more than 25 physician specialists including gastroenterologists, colorectal surgeons, general surgeons, radiation oncologists, medical oncologists, pathologists, family practice physicians and radiologists who comprise the Center.
"It truly is a collaborative effort and our physicians and other specialists do a wonderful job in communicating and coming together to decide what’s best for patients," Norris said.
Nurse Practitioner Janice Leak’s role as St. Francis’ other nurse navigator – she was the first in 2006 – has positioned her as a key link between physicians and patients receiving care for head and neck cancers. The patients Leak works with often go through different treatment phases, often a combination of surgery, radiation and chemotherapy, and that means they will be seen by different physicians and technicians for tests and procedures.
Leak currently works with about 48 patients having head and neck-related cancers; Norris has a caseload of more than 70 patients at St. Francis hospitals in Indianapolis, Beech Grove and Mooresville.
"Cancer treatment can seem very complex and segmented to patients," Leak said. "That’s where a nurse navigator can be a common thread to help weave the patient through the process and so that they feel supported throughout the process."
Cheryl Snooks is one patient who has experienced that process. The business project manager was diagnosed with an oral-related cancer in 2006 at St. Francis and was immediately paired with Leak.
"As you go from diagnosis to treatment, your questions and concerns change," Snooks said. "It was helpful to have Janice there with the answers and to have a positive experience."
As part of the Center’s commitment to provide the newest technology and highest quality of care, Norris explained that all patients are screened for enrollment in clinical trials. These research studies are among nearly 100 now under way and overseen by the St. Francis Cancer Research Foundation.
The attention doesn’t end with treatment. Norris and Leak both follow up with their patients long after their therapies.
St. Francis also has plans to expand its nurse navigator program into lung cancer.
More information about Cancer Care Services at St. Francis is at http://stfrancishospitals.org/cancer.
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