NCT02697760

Brief Summary

To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

February 27, 2016

Last Update Submit

October 20, 2022

Conditions

Cardiac Disease

Keywords

cadmium-zinc-telluride，CZT camerasmyocardial blood flow，MBFmyocardial flow reserve，MFR

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease (CAD) diagnosis

    CAD defined as more than 50% stenosis in any vessel by coronary angiography or computed tomography.

    12 months after the index MPI

Secondary Outcomes (1)

  • MACE (major adverse cardiac events)

    5 years after the index MPI

Interventions

thallium-201RADIATION

Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with clinically suspected coronary artery disease, heart failure, or intermediate and high cardiovascular risks

You may qualify if:

  • Coronary heart disease
  • Clinical diagnosis of heart failure
  • Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons.

You may not qualify if:

  • Significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Thallium-201

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Yen-Wen Wu, MD, PhD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiology Division of Cardiovascular Medical Center, Far Eastern Memorial Hospital

Study Record Dates

First Submitted

February 27, 2016

First Posted

March 3, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

October 1, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)