Clinical Study for AL-CM | NCT04924998

Studies
Clinical Study for AL-CM

NCT04924998

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Jan 31, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Immunoglobulin Light Amyloidosis Cardiomyopathy

Interventions

current treatment of AL-CM

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jun 1, 2031Estimated

Completion Date

Jun 1, 2031Estimated

First Submitted Date

Jun 7, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2023

Last Update Posted Date

Jan 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AL-CM			Drug: current treatment of AL-CM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
current treatment of AL-CM	Drug	current treatment of AL-CM	AL-CM

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with AL-CM

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Recruiting	Hangzhou	Zhejiang		China