Clinical Study for AL-CM

January 29, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy

In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:
          • xiaohong U PAN
          • Phone Number: +8613857116993

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with AL-CM

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AL-CM
Drug: current treatment of AL-CM
current treatment of AL-CM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 10 year
incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)
10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2031

Study Completion (Anticipated)

June 1, 2031

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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