NCT04118530Completed
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
The purpose of this study is to better understand the following aims: 1. Aim 1: To evaluate the rate of recurrent Atrial Fibrillation (AF)/Atrial Flutter (AFL) in hematopoietic stem call transplant (HCST) patients with incident AF/AFL identified during the initial 30 days of the transplant 2. Aim 2: To evaluate incident episodes of 1) stroke/TIA; 2) other thromboembolic events (not stroke/TIA); 3) Heart failure events; 4) Ischemic heart events 3. Aim 3: To evaluate overall implantation safety in this population
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 21 (actual)
- First submitted
- 5 Oct 2019
- Start date
- 21 Apr 2021
- Primary completion date
- 17 Jun 2024
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Atrial fibrillation
- NCT number
- NCT04118530
What you commit to
- Study type: Observational
- Participants enrolled: 21
- From 21 Apr 2021 to the primary completion date, 17 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of atrial fibrillation (AF) or atrial flutter
- Current use of a class IC or III antiarrhythmic medication
Other illness
- AF or other arrhythmia at the time of consent
- Inability to provide informed consent/significant cognitive impairment
Lab values
- Platelets \<50,000 after 90 days post transplantation
Other
- CHADS-VASc \<2
- Continued SCT hospitalization at 90 days
- Inability to receive anticoagulation
- Expected survival less than one year.
Who the study is looking for
- Age ≥18
- CHADS-VASc ≥ 2
- Recovery of platelets to \>50,000 within 90 days of incident atrial fibrillation (AF) diagnosis
- Discharge from the incident stem cell transplant (SCT) hospitalization
- Normal sinus rhythm at the time of consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.