NCT07435168

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2024Apr 2027

First Submitted

Initial submission to the registry

March 14, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 27, 2026

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

March 14, 2024

Last Update Submit

February 25, 2026

Conditions

Cardiac AmyloidosisChest Pain

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ATTR-CA in patients experiencing chest pain

    Up to 4 weeks

Study Arms (1)

Interventional group

OTHER
Other: Screening thourgh examinations including bonescintigraphy

Interventions

Screening thourgh examinations including bonescintigraphyOTHER

Clinical examination, blood samples, echo, bone scintigraphy

Interventional group

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous history of amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, FamilialChest Pain

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis DeficienciesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Navid Noory, MD

CONTACT

4535453108navid.noory@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor, Consultant Cardiologist, DMSc

Study Record Dates

First Submitted

March 14, 2024

First Posted

February 27, 2026

Study Start

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 27, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)