CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis | NCT07435168

Studies
CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis

NCT07435168

Sponsor

Rigshospitalet, Denmark

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Cardiac Amyloidosis
Chest Pain

Interventions

Screening thourgh examinations including bonescintigraphy

Countries

Denmark

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

Nov 2025

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

Apr 1, 2024Actual

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

Mar 14, 2024

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Feb 27, 2026Actual

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

Feb 25, 2026

Last Update Posted Date

Feb 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emil Loldrup Fosbol, MD, Professor, Consultant Cardiologist, DMSc, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

The objective of this observational, prospective study is to determine the prevalence of Cardiac Amyloidosis (CA) in males over the age of 65 who experience chest pain but show no signs of coronary artery disease (CAD).

Prior to inclusion, all patients will have undergone a CT coronary angiogram or an Rb-PET scan to rule out the possibility of CAD.

Participants will be subject to several examinations, including blood tests, urine samples, ECG, echocardiography, and bone scintigraphy. An endomyocardial biopsy may be conducted if necessary.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional group	Other		Other: Screening thourgh examinations including bonescintigraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Screening thourgh examinations including bonescintigraphy	Other	Clinical examination, blood samples, echo, bone scintigraphy	Interventional group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of ATTR-CA in patients experiencing chest pain		Up to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No signs of CAD through Rb-PET and/or CT coronary arteriogram

Exclusion Criteria:

Previous history of amyloidosis

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Navid Noory, MD	Contact	4535453108		navid.noory@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet	Recruiting	Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D028227	Amyloid Neuropathies, Familial
D002637	Chest Pain

Ancestor Terms

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies

Browse Leaves

Not provided

Browse Branches

Not provided