THE QT REGISTRY | A GLOBAL REGISTRY ON THE DANGERS OF QT PROLONGATION

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The Canadian Heart Research Centre is a, not-for-profit, academic clinical research organization dedicated to providing quality medical research and education

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QT-prolonging drugs are associated with an almost three-fold increased risk of
sudden cardiac death. 2
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PEN

the HeartCheck™ PEN Handheld ECG Device
is required in order to take part in the QT Registry

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CardioComm Solutions software enables electrocardiography (ECG) data to be transmitted, received and managed anywhere in the world using standard computers, wireless devices, enterprise networks, telephones, or the Internet.

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Home Registration The QT Study QT Prolongation Contact  
 

You have been identified by your physician as being potentially at risk for QT prolongation (QT) as a result of a chronic condition or because of the unknown or uncertain effects of the medications you are taking.

QT prolongation is a heart condition that can lead to sudden cardiac death.
The QT interval refers to the time it takes for the electrical signal to pass through the lower chambers of your heart to the time your heart is ready for its next beat. If it takes longer than normal your risk for sudden cardiac death can be as much as 3 times higher than someone with a normal QT interval.1

The only method of detecting QT prolongation is by ECG (electrocardiogram) testing. Since, in many cases, a prolonged QT interval may not always present itself at the time of testing, monitoring QT is best achieved when ECG tests can be taken on a frequent basis over an extended period of time.

You are invited to participate in a global registry conducted by the Canadian Heart Research Centre, in collaboration with CardioComm Solutions, Inc.

The registry aims to better understand the frequency and dangers of QT prolongation by monitoring the ECGs of at-risk patients like yourself.

Participants in the QT Registry may potentially receive benefit by having their ECGs monitored for QT prolongation on a monthly basis for a two year period (24 monitoring instances).

 
 
Register for the QT Study

 

What is required?

You will be required to take one ECG reading per month over a 2 year period using an FDA/Health Canada-cleared portable ECG device. Using the software included with the device, you are required to login to the QT Registry website and transmit your heart readings to an ECG coordinating centre for analysis each month.

Qualified participants are required to purchase the HeartCheck™ PEN device through the QT Registry website in order to take part in the QT Registry. If a participant does not have a HeartCheck™ PEN device, click here to purchase the device at a special QT Registry rate.

+ to learn more about the HeartCheck™ PEN or to purchase your device click here


Next steps

1) Once you've received your HeartCheck PEN device, you can register online at www.chrc.net/qtstudy using the device's serial number and your physician's
phone number.
  Once registered, you will receive an email containing your unique QT Registry login information and a link to download GEMS™ Home, the ECG management software needed to transmit your ECGs to the QT Registry ECG coordinating Centre.
2) Login to the QT Registry to complete your online case report form.
3) Download and install the GEMS™ Home software on your computer. Once installed you may begin taking heart readings and transmitting them to the QT Registry ECG coordinating Centre on a monthly basis for review.
4) Both you and your physician will be notified if QT prolongation is detected.


+ click here to download PDF invitation

 

Protocol Title: Longitudinal Registry of QT monitoring
Protocol Number: CHRC2012-QT003
Principal Investigator: David Newman, M.D.

 

In order to take part in this study you must purchase the hand-held ECG PEN device through the QT Registry website. 

The primary objective of this research is to provide a long term assessment of changes in QT/QTc in patients exposed to medications as a result of medical management of their condition(s).

Secondary objectives of this research aim to study the impact of specific medications on QT/QTc, to study the long-term variability of heart rate and QRS duration in relation to the long term variability of the QT, to study the feasibility of self-monitoring in the community and to establish the optimal frequency of this monitoring.

Participation is completely voluntary and there is absolutely no obligation for you to participate. This study is organized and coordinated by the Canadian Heart Research Centre (CHRC), an academic research organization. You do not have to participate in this study to purchase this device. The device is available over the counter for $259 (USD). The device purchased through the designated website is $350 (USD) and includes 2 years of monthly monitoring.

You may potentially receive benefit by agreeing to participate by having your ECGs monitored for QT prolongation on a monthly basis. In the future, people may also benefit from the information obtained from this research.

If you agree to participate you will be asked to submit a 30 second ECG from your device every month for two years using SMART Monitoring. There are no other requirements for you to participate. You may stop your participation at any time by clicking the button “Stop Participation”.

By clicking the button “Agree to participate” you agree to have the results of your QT monitoring used together for analysis with the results of other participants. While the results of your monitoring may be disclosed in scientific reports, your identity will remain masked and will not be disclosed. Information that could be used to identify you will only be shared with researchers participating in this study. Information that likely could be used to identify you will not be shared with other researchers. The CHRC will share the records generated from this research with regulatory agencies such as the Food and Drug Administration, Health Canada and the Western Institutional Review Board. This information is shared so the research can be conducted and properly monitored. The people receiving this information may not be required to protect it and your information may be re-disclosed without your permission. If you do not provide permission to use your information you cannot be in the study.

By clicking on the “Agree to participate” button you also agree that the results of your QT monitoring, including any alerts if the QT prolongation is detected, will be made available to your doctor and/or pharmacist, providing that your doctor and/or pharmacist’s name(s) and contact information have been provided to us by you.

The information that we will ask you to provide to us includes:

Your neurological /psychiatric condition(s): epilepsy, multiple sclerosis (MS), depression, attention deficit-hyperactivity disorder (ADHD), Parkinson’s disease, schizophrenia

Your chest/pulmonary condition(s): asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis

Your endocrine condition(s): diabetes mellitus, thyroid disease, Addison’s disease, Diabetes insipidus, hyperlipidemia

Your cardiac condition(s): atrial fibrillation or other arrhythmia, CVA (stroke) / TIA (transient ischemic attack), congestive heart failure (CHF) / cardiomyopathy, pacemaker/ implantable cardioverter defibrillator (ICD), coronary heart disease (CAD) (myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention), hypertension, heart failure

Cancer: of the breast, prostate, or other cancer
Whether or not you are a smoker

Your immune condition(s): arthritis, Systemic lupus erythematosus (SLE), Crohn’s disease, ulcerative colitis, psoriasis, allergies

Your liver condition, chronic renal disease, hemophilia
Whether or not you have been diagnosed as having glaucoma

Your HIV status, and

Any infections you have requiring antibiotics

All information transmitted through the internet will be done via a secure website. Additional information about you that will be collected will include: your name, date of birth and gender, your e-mail address and phone number, the e-mail address where the alert - in case of QT prolongation - is to be sent (this could be your physician, your pharmacist or only you) and information about your medical condition, your symptoms and the medication you are taking.

There are no known risks associated with the use of the ECG PEN device.

Your participation in this registry may be stopped at any time by the CHRC without your consent for any reason. The cost to participate in the QT Registry is $350.00 and includes the cost of the device ($259.00 plus the readings and associated administrative costs in the research). The regular cost of the device only (outside of the special registry rate) is $259.00.

There will be no payments provided to you for your participation.

If you have questions about this research or if you think that you have been harmed as a result of joining this research you may contact Caroline Spindler at the Canadian Heart Research Centre (tel: 416-977-8010; email: spindlerc@chrc.net) or Dr. David Newman at 905-472-7127.

If you have questions about your rights as a research subject or if you have questions, concerns or complaints about the research, you may contact:

Western Institutional Review Board® (WIRB®)
3535 Seventh Avenue, SW
Olympia, Washington  98502
Telephone:  1-800-562-4789 or 360-252-2500
E-mail: Help@wirb.com

WIRB is a group of people who independently review research.

Please click one of the buttons below to indicate whether you would like to participate or not. By agreeing, you understand that you have not given up any of your legal rights. Your condition may not get better or may get worse during this study. Any changes in your condition will not be as a result of your participation in this study. Your decision to be in this study is voluntary.  You will not be penalized or lose benefits if you decide not to participate or if you decide to stop participating. 

Agree to participate - by clicking this button you agree to participate in the QT Registry. You may stop participation at any time.

Stop Participation - by clicking this button you refuse to participate in the QT Registry or would like to stop your participation. If you stop your participation any information collected before you withdraw may still be used.



Register for the QT Study
Home Registration The QT Study QT Prolongation Contact  


1 - Dr. Arthur J Moss, MD - Journal of the American College of Cardiology - www.content.onlinejacc.org/article.aspx?articleid=1137209
2 -European Heart Journal (2005) 26, 2007–2012 - doi:10.1093/eurheartj/ehi312 -
Non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death

* only the QT interval will be analyzed during this Registry.