Clinical Study for AL-CM

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924998
Collaborator
(none)
400
1
120
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: current treatment of AL-CM

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy
Anticipated Study Start Date :
Jun 6, 2021
Anticipated Primary Completion Date :
Jun 6, 2031
Anticipated Study Completion Date :
Jun 6, 2031

Arms and Interventions

Arm Intervention/Treatment
AL-CM

Drug: current treatment of AL-CM
current treatment of AL-CM

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome [10 year]

    Cardiovascular death, myocardial infarction, and stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04924998
Other Study ID Numbers:
  • 2021-0133
First Posted:
Jun 14, 2021
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2021