APS ACTION International Clinical Database and Repository – Top 10 Series

Top 10 Points that Antiphospholipid Antibody-positive Patients Should Know About APS ACTION International Clinical Database and Repository

By JoAnn Vega, CCRC; Ayşe Bahar Keleşoğlu Dinçer, MDDoruk Erkan, MD, MPH

1. What is antiphospholipid syndrome (APS)?

Antiphospholipid syndrome (APS) is a systemic autoimmune disorder in which the patient’s immune system makes antibodies (antiphospholipid antibodies [aPL]) that increase the risk of blood clots (thickened blood) and pregnancy complications, including miscarriages. Other clinical problems related to aPL include livedo reticularis/racemosa (a lacey purple pattern on the skin), heart valve disease, low platelet count, anemia, and kidney disease. For more information on APS, please visit our main antiphospholipid syndrome page.

2. What is APS ACTION?

APS ACTION – Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking – is an international research network focused on conducting clinical research studies with a commitment to prevent, treat, and cure aPL-associated symptoms.

The network was created in November 2010 by 25 international physician scientists; currently there are 80 members from 32 centers worldwide, including Hospital for Special Surgery, which is the lead coordinating center. To get more information on APS ACTION, please visit this page.

3. What is a research registry and what is APS ACTION International Clinical Database and Repository ("APS ACTION registry")?

A research registry is a collection of information about patients who have a particular disease or condition. Investigators maintain this information for use in future research studies.

The APS ACTION International Clinical Database and Repository, also called “registry” is a multi-center collaborative effort of a secure, web-based clinical database of persistently antiphospholipid antibody (aPL)-positive patients so that the natural course of these patients can be followed over at least 10 years. For those patients who complete their 10-year follow-ups, they are invited to enroll into the extension of the registry.

Conclusions drawn from a large data set are more reliable than if they were based on data collected from only a few people in a study in a limited location. The APS ACTION registry is not only a large dataset, but it is composed of a collaborative effort from multiple countries. This kind of communication and sharing of information allows for the potential of expedited research.

The APS ACTION Registry is taking place in the United States, Canada, Europe, South America, and Asia. Currently there are approximately 1,300 international patients included in the registry.

4. Why is the APS ACTION registry important?

Much remains to be learned about the cause, full range of symptoms, diagnosis, and treatment for APS. Information gathered through the APS ACTION registry facilitates a better assessment of aPL-related clinical problems and helps determine the optimal management of aPL-positive patients.

5. What are the benefits of participating in the APS ACTION registry?

By participating in this registry, you can be a part of a groundbreaking effort to uncover new information about APS, its causes and treatment. In addition:

  • You can be informed of other research studies conducted by HSS that you may be interested in participating in (all future research studies based on the information in this registry will be subject to oversight by APS ACTION Executive Committee and Hospital for Special Surgery’s Institutional Review Board).
  • You will receive standard cardiovascular disease and blood clot prevention counseling for special situations (e.g., long flights, surgery).

6. What does participation in the APS ACTION registry involve?

Your participation will involve a total of 11 study visits and 10 telephone interviews over a period of 10 years. Annual study visits are expected to last 20 to 30 minutes and can take place at the time of your routine visits to Hospital for Special Surgery. During the first 10-year period, no additional visits are required unless you develop new aPL-related clinical events such as blood clots or pregnancy losses.

At each visit, 20ml to 50ml (4 to 10 teaspoons) of blood will be drawn and information will be taken. This is done by collecting medical history, physical exam findings, and laboratory tests; storing the information in a database; and using that information at a later time for research studies. For example, information in this registry may be used in a future study to evaluate thrombosis prevention in aPL-positive patients with no history of thrombosis.

There is no cost to you for your participation. Your decision to take part in this registry is completely voluntary. You will sign a consent form when you enroll, and you may withdraw from the registry at any time.

After the first 10-year participation in the registry is completed, patients are given the opportunity to decide if they would like to continue in the registry under the “extension period”. Enrollment in the extension is optional and not required to participate in the main registry.

7. Am I eligible for the APS ACTION registry?

You are eligible if your blood test is persistently positive for at least one aPL test. These include:

  • lupus anticoagulant (LA) test
  • anticardiolipin antibody (aCL)
  • anti-Beta-2-glycoprotein-I (aβ2GPI) antibody

8. Who will be accessing my information?

Hospital for Special Surgery investigators in this study are Dr. Doruk Erkan (APS ACTION Executive Committee Co-Chair, Global and HSS Registry Principal Investigator), Dr Medha Barbhaiya (co-investigator), Dr. Jane Salmon (co-investigator), Dr. Michael Lockshin (co-investigator), and JoAnn Vega (Study Global Coordinator).

APS ACTION investigators at the other participating centers may be able to access your data for future research. However, Hospital for Special Surgery investigators remove any personal identification (including the patient’s name) from the information stored in the registry and will store the blood samples in a separate, secure location. Thus, your personal information kept private and APS ACTION investigators are granted access only to data that are no longer identifiable.

9. Are there other ongoing APS ACTION projects in addition to the registry?

Since its creation, APS ACTION has developed an established track record with achievements including active participation in major scientific meetings, many publications in journals, and useful interactions with patients and patient organizations.

Since 2010, a total of 28 publications have been published in highly ranked journals. For the full list of publications, please visit apsaction.com/publications. In addition, over 50 podium and poster presentations at international congresses have been completed.

The ultimate goal of APS ACTION is to improve the care of APS patients, and in order to achieve this goal, many other projects are still going on.

10. How do I become involved with the APS ACTION registry?

For more information on the APS ACTION Registry and/or to participate in the registry, please contact the Study Coordinator, or ask your doctor to do so for you.

Contact information

JoAnn Vega, CRCC
Hospital for Special Surgery Research Coordinator
APS ACTION Global Lead Coordinator
Tel: 212.774.2795
Fax: 212.774.7298
Email: vegaj@hss.edu
www.apsaction.org

Authors

JoAnn Vega, CCRC
APS ACTION Global Lead Coordinator

Ayşe Bahar Keleşoğlu Dinçer, MD
Visiting Physician

Doruk Erkan, MD, MPH
Attending Rheumatologist, Hospital for Special Surgery
Professor of Medicine, Weill Cornell Medical College

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