Have an interesting story to share? Email [email protected]Page 1 Contents LRP Leaderboard............ Enrollment Progress .......... MACE Reporting Procedures..... Things to Remember .......... Tips from the Lead Clinical Specialist ................. Study Coordinator of the Quarter. . Study Coordinator’s Corner ..... Meet the Core Lab Development Team .......... Investigator-Initiated Grant Proposals................. Data Upload AGMednet iCloud. .. LRP Leaderboard Methodist Hospital, Merrillville IN At left: Dr. James Muller, CMO Infraredx and Dr. Andre Artis Principal Investigator: Dr. Andre Artis Research Coordinators: Kim Armstrong 1 2 2 3 3 4 5 5 6 6 Join us in congratulating Methodist Hospital for being the site of the quarter! The LRP Study Newsletter November 2014 | Volume 1, Issue 2 In a case report (see the Journal of Invasive Cardiology http://www.invasivecardiology. com/content/infraredx), Dr. Artis describes unexpected findings in a pre-operative patient. Although the patient had low LDL and no history of coronary artery disease, a hazy segment on angiography prompted further examination. e TVC Imaging System confirmed the absence of a tight stenosis but revealed a large lipid core plaque (LCP). Although ruptured LCP is associated with most heart attacks, current practices may not adequately prevent these events. e Lipid-Rich Plaque Study was designed in response to this need. e LRP Study is the largest effort to identify and monitor plaques suspected to be vulnerable to rupture. If and when prediction of coronary events by NIRS is achieved, the LRP Study will transition to a blinded, randomized study of TVC-guided treatment. e potential to specifically identify vulnerable plaques has many excited to see the next steps for this diagnostic catheter. So what did TVC do for Dr. Artis’ patient? e combined information of NIRS-IVUS prompted Dr. Artis to initiate statin and aspirin therapy which could reduce the risk of an event during or aſter surgery. To read more about statins stabilizing plaque during PCI, see Souza et al. JACC 2014. MLA 7mm 2 Plaque burden: 61% maxLCBI 4mm 803 Methodist Hospital has enrolled a total of 36 subjects in the LRP Study in a short number of weeks since initiation. eir dedi- cation to informing the community about the significance of the LRP study has made them one of the top five enrolling sites in the study. Dr. Artis is intrigued by the LRP study and believes it will be a unique opportunity to look at patients with a better under- standing of plaque composition. Understanding plaque composition may lead to improvements in health, longevity, and quality of life. Kim Armstrong, research coordinator, plays an important role in the success of this site by pre-screening all coronary patients to identify those most likely to be enrolled. Her energy and drive to support cases drives weekly enrollment. e cath lab team is genuinely interested in the study and excited to take part in groundbreaking research. MLA 7mm 2 Plaque burden 61% maxLCBI 4mm 803
Tips from the Lead Clinical Specialist . . . . . . . . . . . . . . . . .
Study Coordinator of the Quarter. .
Study Coordinator’s Corner . . . . .
Meet the Core Lab Development Team . . . . . . . . . .
Investigator-Initiated Grant
Proposals. . . . . . . . . . . . . . . . .
Data Upload AGMednet iCloud. . .
L R P L e a d e r b o a r dMet ho dis t Hospit a l , Mer r i l lv i l l e IN
At left: Dr. James Muller, CMO Infraredx and Dr. Andre Artis
Principal Investigator: Dr. Andre ArtisResearch Coordinators: Kim Armstrong
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Join us in congratulating Methodist Hospital for being the site of the quarter!
The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
In a case report (see the Journal of Invasive Cardiology http://www.invasivecardiology.com/content/infraredx), Dr. Artis describes unexpected findings in a pre-operative
patient. Although the patient had low LDL and no history of coronary artery disease, a hazy segment on angiography prompted further examination. The
TVC Imaging System confirmed the absence of a tight stenosis but revealed a large lipid core plaque (LCP). Although ruptured LCP is associated with most heart attacks, current practices may not adequately prevent these events. The Lipid-Rich Plaque Study was designed in response to this need. The LRP Study is the largest effort to identify and monitor plaques suspected to be vulnerable to rupture. If and when prediction of coronary events by NIRS is achieved, the LRP Study will transition to a blinded, randomized study of TVC-guided treatment. The potential to specifically identify vulnerable plaques has many excited to see the next
steps for this diagnostic catheter.
So what did TVC do for Dr. Artis’ patient? The combined information of NIRS-IVUS prompted Dr. Artis to initiate statin and aspirin therapy which
could reduce the risk of an event during or after surgery. To read more about statins stabilizing plaque during PCI, see Souza et al. JACC 2014.
MLA 7mm2
Plaque burden: 61%maxLCBI4 mm 803
Methodist Hospital has enrolled a total of 36 subjects in the LRP Study in a short number of weeks since initiation. Their dedi-cation to informing the community about the significance of the LRP study has made them one of the top five enrolling sites in the study.
Dr. Artis is intrigued by the LRP study and believes it will be a unique opportunity to look at patients with a better under-standing of plaque composition. Understanding plaque composition may lead to improvements in health, longevity, and quality of life. Kim Armstrong, research coordinator, plays an important role in the success of this site by pre-screening all coronary patients to identify those most likely to be enrolled. Her energy and drive to support cases drives weekly enrollment. The cath lab team is genuinely interested in the study and excited to take part in groundbreaking research.
MLA 7mm2
Plaque burden 61%maxLCBI4mm 803
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The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
Enrollment ProgressCongratulations to the top ten enrolling sites in the LRP Study
Welcome New InvestigatorsCongratulations to the investigators who have been activated since our last LRP Newsletter.
Jonathan Tobis, MD University of California, Los Angeles, CAMark Zainea, MD McLaren Macomb Hospital, MIDaniel Lee, MD McLaren Bay Regional, MIChristopher Kim, MD Davis Hospital and Medical Center, UTAugusto Villa, MD Palm Beach Gardens Medical Center, FLGanesh Raveendran, MD University of Minnesota Medical Center, MNJose Arias, MD Florida Hospital Orlando, FLAndrei Pop, MD Alexian Brothers Heart and Vascular Institute, ILVarinder Singh, MD North Shore—LIJ Health System, NY
LRP Is Now GlobalWe would like to welcome Dr. Joanna Wykrzykowska at the Academic Medical Center in Amsterdam, Netherlands and
Dr. Andrejs Erglis at the Latvian Centre of Cardiology in Riga, Latvia.
MACE Reporting ProceduresIn order to analyze the primary endpoints of the LRP study, it is important to report and submit data associ-ated with MACE events for all enrolled patients. Detailed procedures to report these events to the sponsor are found in CS0171 LRP Adverse Event Reporting Procedures. The step-by-step submission process is shown on the right:
LRP MACE Reporting
1. Complete & Fax CF0223 LRP AES Notification Form
2. Send data applicable to AES according to CF0224 Checklist (Source Document, Angio, NIRS-IVUS)
3. Enter data into EDC
4. Resolve data queries
Columbia University Medical Center, NY Ziad Ali MD PhD, Luz Jaquez
Medical University of South Carolina, SC Eric Powers MD, Lisa Carson
Methodist Hospital, IN Andre ArtisMD, Kim Armstrong RN
St. John’s Springfield, IL NileshGoswami MD, Shawn Smith
Charleston Area Medical Center , WV Stephen Lewis MD, Joy Hogan
Washington Hospital Center, DC Ron Waksman MD, Dini Hemantha
Davis Medical Center, UT Christopher Kim MD, Eric Mansell
Central Baptist Hospital, KY William Skinner MD, Jeannie Chapman RN
CrittentonShelton Heart Center, MI SamerKazziha MD, Mike Cribbs
Emory University Hospital, GA Habib Samady MD, Emad Azrumbly MD 19
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58Columbia University Medical Center, NY Ziad Ali MD PhD, Luz Jaquez
Medical University of South Carolina, SC Eric Powers MD, Lisa Carson
Methodist Hospital, IN Andre ArtisMD, Kim Armstrong RN
St. John’s Springfield, IL NileshGoswami MD, Shawn Smith
Charleston Area Medical Center , WV Stephen Lewis MD, Joy Hogan
Washington Hospital Center, DC Ron Waksman MD, Dini Hemantha
Davis Medical Center, UT Christopher Kim MD, Eric Mansell
Central Baptist Hospital, KY William Skinner MD, Jeannie Chapman RN
CrittentonShelton Heart Center, MI SamerKazziha MD, Mike Cribbs
Emory University Hospital, GA Habib Samady MD, Emad Azrumbly MD
Chemogram quality checks should be performed for all blinded runs. You will see one of these messages after the pullback is completed and the regions of interest are selected:
TVC Imaging for the LRP Study: Things to Remember
Upcoming Events
CRT Conference, February 21-25
ACC Conference, March 12-16
For company news and product information, visit us online at:
www.infraredx.com
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Tips from Jason Richard, our lead Clinical Specialist:
• Perform all clinically indicated treatment prior to performing pullbacks in non-culprit arteries to ensure the primary treatment is successful without complications.
• Exclude all old and new stents and 5mm beyond both ends of the stent when calculating the 50mm minimum scanning requirement for patient eligibility.
• Record an angiographic cine of the proximal and distal placement of the NIRS-IVUS catheter.
• Label each pullback with the vessel name within the TVC console.
• Scan as many arteries and as much artery length within each scan as possible.
• Perform a post-stenting scan of the entire culprit artery after stenting, if possible.
The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
If Message 1 “Data Quality Not Acceptable” displays, review the coronary anatomy to determine if the following features are present: multiple layers of stents, tortuous arteries, or thrombus. If these features are present, continue with the procedure. If multiple layers of stents, tortuous arteries or thrombus are not present, then perform the quality check by one of these methods:
Method 1: The sterile operator can place a mark at the beginning of the pullback and at the end prior to stopping the scan. This will automatically generate a regional measurement and produce a “Data Quality Acceptable” or “Data Quality Not Acceptable” result on the screen. If a “Data Quality Not Acceptable” displays, select a different region within the chemogram to reassess the data quality.
OR
Method 2 : After the blinded scan is complete, the non-sterile operator can place distal and proximal markers using the Flag Button to create a region, which will generate the “Data Quality Acceptable” or “Data Quality Not Acceptable” result on the screen. If a “Data Quality Not Acceptable” displays, select a different region within the chemogram to reassess the data quality.
Congratulations to Lisa Carson for being selected as the research coordinator of the quarter! Lisa was selected based on her incredible enthusiasm, efficiency in enrolling patients and ability to motivate the cath lab team. Other successes include:
• Encouraging fellows to identify patients that are likely to qualify for enrollment
• Accurately entering data into the EDC and resolving queries within 7 days, ensuring all data is query-free!
• Submitting angiograms, NIRS-IVUS data and cath reports immediately after procedures
Lisa’s enthusiasm for the LRP Study gained her the nickname “LRP Lisa” by her colleagues. We sincerely appreciate the dedication and effort she puts into driving MUSC to be one of the top enrolling sites-MUSC submits at least 2 patients each week for the LRP study!
Study Coordinator of the Month: “LRP Lisa” Carson
Study Coordinator’s Corner1. LRP Website Log onto www.LRPstudy.com to see news updates and enrollment progress.
2. LRP Quarterly Conference Calls An LRP quarterly conference will be held to discuss enrollment status, challenges, and
other topics related to the LRP Study.
3. New Training for New Research Staff Please contact your designated site monitor to schedule LRP protocol or EDC training
for any new staff, including research coordinators and sub-Investigators.
4. Physician Referral Letters A physician referral letter template is being provided for any site that would like to notify referring physicians about the
LRP Study detailing patient inclusion/exclusion criteria. Please contact your site monitor for the letter template.
Forms TrainingNews
www.LRPstudy.com
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The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
From left: Dr. Christopher Nielsen, Lisa Carson, Dr. Eric Powers, Ashley Moduno.
S i te : Medical University of South CarolinaResearch Coordinator: Lisa Carson
Me e t t h e Me d s t a r C o r e L a b Te a m !
From left: Susan Fisher, Hideaki Ota MD, Max Kollmer, Mia-Ashley Spad, Karina Kardenas MD PhD, Anh Bui MD, Smita Negi MD, Marco de Magalhaes Pereira MD.
Investigator-Initiated Grant ProposalsIf you are interested in conducting an investigator-initiated study
using the TVC Imaging System, please submit all inquiries to Infraredx:Priti Shah, Manager of Clinical Research
Medstar, the core lab for the LRP Study, receives and analyzes NIRS-IVUS TVC Imaging data and angiograms for each enrolled patient. They measure the amount of non-culprit segments obtained for patients, calculate the max 4mm LCBI, and then allocate patients to follow-up assignment. This work is all completed in a short period to ensure sites receive follow-up allocations within 30 days of enrollment.
Medstar developed the EDC system for the LRP study. Working directly with Infraredx, they created a user-friendly data entry system to improve patient data storage and reduce the need for paper-based case report forms. Medstar also collaborates with international LRP sites to streamline in-house monitoring procedures.
1,000 Patients
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The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
Each week, enrollment numbers climb with contributions from almost all sites. The LRP Study will soon surpass 400 patients. By quickly reaching the enrollment goal, the study can determine if LRPs detected by TVC Imaging are tied to events. Detection of vulnerable plaques and vulnerable patients are the two primary endpoints of the study. Thank you for your hard work and dedication to this study!
398 Patients
Plug USB into a computer.De-identify each zip file using TVC anonymizing application
The LRP Study NewsletterNovember 2014 | Volume 1, Issue 2
TVC Imaging & Angiogram Data: Submission made Easy & Fast!
In September, the AGMedNet iCloud solution successfully launched to allow quick uploads of angiogram and NIRS-IVUS TVC Imaging data. This will reduce the time of burning and shipping CD’s and will allow the core lab to perform analysis and follow-up group assignments quickly. Please contact your CRA for installation and a quick 15 minute training. Remember to submit imaging data within 7 days of the enrollment procedure.
Advantages:1. No more burning CD’s2. No more shipping labels and scheduling pick-ups3. Upload more than one patient simultaneously4. Receive follow-up group assignment faster
1. Submit an invoice each month for activities completed.
2. The invoice template is available upon request. This template has all required information to allow quick and accurate verification of enrollment milestones.
3. Provide appropriate information for procedure verification. If you decide not to use the template, the following information in required to verify procedures:
a. Procedure Type / Milestone
b. Patient ID #
c. Date procedure performed (applies screen failures only)
4. Submit an invoice after all data has been submitted and verified by Infraredx.
