ClinicalTrials.gov record NCT04924998
Clinical Study for AL-CM
Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective observational study of people diagnosed with Immunoglobulin Light Amyloidosis Cardiomyopathy (AL-CM). It observes current treatments and follows participants long-term to record outcomes. The study will track major cardiovascular events (cardiovascular death, myocardial infarction, stroke, and hospitalized unstable angina) over a 10-year timeframe.
What it is studying. The study is observing how current treatments for AL-CM relate to long-term outcomes, specifically measuring the incidence of major cardiovascular events (MACE-4: cardiovascular death, myocardial infarction, stroke, hospitalized unstable angina) over 10 years.
What the researchers hope to learn. To observe treatment patterns and conduct long-term follow-up in AL-CM, and to measure 10-year incidences of major cardiovascular events (MACE-4).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- current treatment of AL-CM
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine;
- Patients have the ability to understand the test, can cooperate with investigators.
Exclusion criteria
- Unable to understand or unwilling to fill in informed consent forms or follow visitors
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants continue their current treatment while the study observes outcomes and follows them over time. You would be asked to give informed consent and to cooperate with investigators during scheduled follow-up contacts or visits. The study will record health events, especially major cardiovascular events (cardiovascular death, myocardial infarction, stroke, and hospitalized unstable angina), with follow-up lasting up to 10 years.
How the study is structured. A prospective, observational cohort study. Participants continue their usual/current treatment (treatments are not assigned by the study) while the study team collects data and follows health outcomes over time.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Jun 1, 2021
- Primary completion
- Jun 1, 2031 (estimated)
- Study completion
- Jun 1, 2031 (estimated)
- Target enrollment
- 400 participants (estimated)
- Last updated on registry
- Jan 31, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Participating sites (1)
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
Hangzhou, Zhejiang · China
- xiaohong U PAN · +8613857116993
Terms used on this page · explanations by MedicalUpdates.ai
- long-term follow-up
- Observation that continues for years after the study treatment, often required for gene and cell therapies.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials