COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people who had possible heart inflammation (myocarditis or pericarditis) within 42 days after a COVID-19 vaccine. Vaccinated relatives or volunteers without heart problems can join as a comparison group.

Életkor

5 years and older

Nem

All sexes

A betegség stádiuma

Suspected myocarditis or pericarditis starting within 42 days of a COVID-19 vaccine. People need heart symptoms such as chest pain or shortness of breath, or at least two general symptoms such as tiredness or cough. People with no symptoms can join if tissue tests, or blood tests together with heart scans, show changes.

Korábbi kezelés

Must have received a COVID-19 vaccine. Must be a person who is able to get a COVID-19 vaccine.

Biomarker vagy leletérték

At least one abnormal finding: raised Troponin T, Troponin I or CK-MB; abnormal heart MRI or echo; new or worse heart rhythm problems on ECG, telemetry or Holter monitor; fluid or inflammation around the heart, or raised ESR, CRP, hs-CRP or D-Dimer; pericardial friction rub or pulsus paradoxus on exam; enlarged heart on chest X-ray; or inflammation seen in heart tissue.

A részvétel fő kizáró okai

• Another clear cause for the symptoms, such as an infection of the heart like Lyme carditis
• Symptoms that started more than 42 days after the vaccine

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Myocarditis and pericarditis are inflammatory diseases of the myocardium and pericardium, and can be related to different causes, including vaccines. In the past, some people developed inflammatory heart disease after receiving a live or inactive virus vaccine (smallpox vaccine or flu vaccine). Myocarditis was also seen in people with COVID-19. More recently, many countries reported that some people have developed an inflammatory condition of the myocardium or pericardium after receiving a vaccine for COVID-19.

A vizsgálat 3 csoportja

• Prospective (cases)

  Patients who develop new symptoms of suspected myocarditis/pericarditis within 42 days of receiving a COVID-19 vaccination. The clinical symptoms include chest pain, pressure, or discomfort; dyspnea, shortness of breath, or pain with breathing; palpitations; diaphoresis or sudden death. The symptoms can also be non-specific, including fatigue, abdominal pain, dizziness or syncope, edema, cough or irritability, vomiting, poor feeding, tachypnea or lethargy in young children

• Prospective (Control Negative)

  Family members/relatives who have been vaccinated in a similar timeframe with the participants but did not experience myocarditis side-effects. If a relative is not available, then a voluntary control who has received the same COVID-19 vaccine in a similar time frame can be recruited.

• Retrospective

  Identified patients, previously diagnosed with the condition, at participating centers