The CZT Dynamic Myocardial Perfusion Imaging

Cardiac Disease Clinical Trial

— CZT  

Official title:

The Quantification, Clinical Application of Dynamic Imaging Using Cadmium-zinc-telluride (CZT) Cameras to Assess Myocardial Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697760
• Other study ID #: 104069_F
• Status: Completed
• Start date: September 2015
• Est. completion date: October 2022

Study information

• Verified date: October 2022
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations.

The present project aims 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Coronary heart disease

2. Clinical diagnosis of heart failure

3. 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Radiation:
• thallium-201
Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE (major adverse cardiac events)	revascularization, acute myocardial infarction, hospitalization for heart failure, cardiac death, non-cardiac death	5 years after the index MPI