In Stockholm there is an ongoing study with the aim to study if screening to detect atrial fibrillation in 75-76 year olds will result better treatment with anticoagulation and thereby lowering stroke incidence. The study also investigates to which extent patients who already have atrial fibrillation have anticoagulation therapy. This is the reason you get this information and inquiry. The study is conducted by KTA Prim, Karolinska university hospital.
What is the rationale behind the study?
Atrial fibrillation is the most common arrhythmia of the heart and the incidence increases with age. The condition makes the heartbeat irregular and the symptoms can vary greatly, in some cases one can have atrial fibrillation without any symptoms at all. It may therefore be of value to try to discover atrial fibrillation by screening. We will also investigate if other methods than ECG can help discover atrial fibrillation.
To do this we will take a blood sample from your arm veins to analyze a substance in the blood whose value increases if you have atrial fibrillation or if the heart is strained. The result of the blood sample will determine what further investigations will be done. We will also study some different ambulant ECG methods during the study. Finally, we want to know if this method is cost effective and what influences the screening participation.
Atrial fibrillation increases the risk for stroke. This is due to clots that can build in the atria of the heart. The risk for stroke can be reduced by 60-70% by anticoagulation therapy. Anticoagulation therapy also increases the risk for serious bleeding. The study has been approved by the regional ethics committee in Stockholm
What does it mean for me to participate in this study?
Should you accept to participate in this study you will first answer a few questions about your health and your pulse will be registered. Then 5 blood tests will be taken and an ECG will be taken with a so-called thumb-ECG. If the blood sample is normal and if the ecg shows normal heart rhythm no further investigations will be done. Four of the five bloodtests will be saved in a so-called biobank, see below.
If the blood sample is elevated and the ECG shows normal heart rhythm you will be offered further thumb-ECG registration at home with a portable ECG-recorder to detect short episodes of atrial fibrillation. The recordings will be done at least 2 times a day, each recording of 30 seconds duration, for 2 weeks. During the registration both thumbs hold on to a small ECG recorderwhich you take home for the 2 weeks duration.
If you prove to have atrial fibrillation you will be offered a doctors-appointment to decide on anticoagulation therapy.
If your blood sample is very high you will be offered additional examination of the heart with an ultrasound, regardless what your ecg shows.
You will also be followed up for 5 years where we will use the Socialstyrelsen registry to study the occurance of stroke and prescription of oral anticoagulants. This follow-up does not require any activity on your part. Blood examples will be saved to be able to in the future study new substances that might help us detect atrial fibrillation. How you tests will be managed is described under the biobank paragraph.
There is no compensation for traveling costs. Any cost for eventual medication after your participation is covered by the usual pharmaceutical benefits.
Which discomfort/risks does the study entail?
Both atrial fibrillation and oral anticoagulation therapy expose you to certain risks, but the risk reduction achieved by oral anticoagulation is in almost all cases much higher than the risk of undergoing this therapy. Oral anticoagulation is also recommended in the Socialstyrelsen latest national guidlines for cardiac care.
The exams done during the study do not entail any risks in our opinion.
Which benefits can the study entail?
Your participation gives us the opportunity to discover and treat a condition that increases the risk for stroke, as well as giving us valuable knowledge that others can have use for in the future.
How do we collect personal data and protect data integrity
Den studieansvarige läkaren och forskningsgruppen(se kontaktuppgifter nedan) kommer samla in och registrera personuppgifter om dig i syfte att bedöma resultaten av forskningsstudien. Dessa uppgifter kan innefatta: namn, personnummer, adressuppgifter, uppgifter om riskfaktorer för proppbildning samt tum-EKG registrering och tum-EKG di
agnos och andra relevanta delar av din patientjournal. Personuppgifterna från studien
The responsible doctor and the study group (se contactinformation below) will collect and register personal data with the aim to judge the result of the study. This personal data will include name, social number, address, information on risk factors for stroke and thumb-ECG registration, thumb-ECG diagnosis and other relevant parts of your medical records. The personal data from the study will be collected and processed in a data system. Your information will be integrity protected and no one unauthorized will have access to the system.
You have the right to demand in writing which information about you is registered. You have the right to receive such an extract one yearly free of charge. Should it be revealed that something is incorrect this will be corrected. If you wish for a written extract please contact the responsible doctor (see below)
The information will only be available for the personnel involved in the study and will not be used for any other purposes. You have the right to request information about this use of your personal data according to the personuppgiftslagen (PuL) §26 and you do this by writing to the Personuppgiftsombudet, Sissi Myllyniemi, Kansli-och Miljöavdelningen, Norrbacka S3:01, Solna 171 76 Stockholm
Your blood tests will be stored in a biobank number 914 and will be treated according to the Lagen om biobanker i hälso-och sjukvården (2002:297) which regulates how the tests may be stored and used. The tests will be coded, which means it cannot be traced back to you without a certain code key.
In this study different analyses will be performed related to atrial fibrillation and the increased risk for stroke. Your tests can be sent to our laboratory in Sweden or to our partner laboratory within the EU. The tests can be stored for different amounts of time in the wait for analyses.
Who gets access to tests and information?
Only researchers have access to the study and information that can lead to you personally will be removed. The project has been reviewed and approved by an ethics committee.
The results will be published in scientific journals and presented at scientific meeting. Only statistics will be presented and it will not be possible to identify specific individuals in this publication.
You are free to change your mind
Your participation is voluntary and you can at any time cancel your participation without having to explain why. If you decide to withdraw your participation in the study it will not affect your future medical care.
If you wish to withdraw your participation please contact the responsible study nurse or doctor (see contacts below)
Collected information: It is important to note that the study responsible doctor has the right to keep the already collected information and that this information will continue to be part of the study.
Should you change your mind about giving us your blood samples you have the right to have them discarded.
If you want more information on the study, your rights as a patient or if there arise any problems during the study please contact:
Nurses på KTA Prim
08-517 782 02
For the study responsible doctor:
Mårten Rosenqvist, Överläkare/Professor
Sabbatsbergs Sjukhus Dalagatan 9
113 61 Stockholm