Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease
1 other identifier
observational
221
1 country
4
Brief Summary
Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and will receive invasive coronary angiogram are recruited to receive SPECT MBF study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2018
CompletedFirst Submitted
Initial submission to the registry
August 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 2, 2022
January 1, 2021
2.7 years
August 15, 2018
January 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The diagnostic accuracy of MBF and MPI
The diagnostic accuracy of MBF and MPI while angiography is utilized as the reference standard
Through the study completion up to 12 months
Study Arms (1)
Coronary Artery Disease
Suspected or known coronary artery disease
Eligibility Criteria
The study population will be adult male and female patients who have suspected or known CAD are agreed to receive MBF measurements when their MPI scan will be performed clinically.
You may qualify if:
- Age 18 \~ 79 years old
- Any CAD risk factor
- CAD related symptoms
- Intermediate to high probability of CAD
- Suspected or known CAD on a stable medication regime
- Able and willing to comply with the study procedures
- Written informed consent
You may not qualify if:
- History or risk of severe bradycardia
- History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
- Wheezing asthma or COPD
- Known second- or third-degree AV block
- Known hypersensitivity to dipyridamole or adenosine
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
China-Japanese Friendship Hospital
Beijing, China
Fuwai Hospital
Beijing, China
Teda International Cardiovascular Hospital
Tanjin, China
Central China Fuwai Hospital
Zhengzhou, China
Related Publications (1)
Wang L, Zheng Y, Zhang J, Wang M, Wu D, Wang Y, Qiu H, Hsu B, Fang W. Diagnostic value of quantitative myocardial blood flow assessment by NaI(Tl) SPECT in detecting significant stenosis: a prospective, multi-center study. J Nucl Cardiol. 2023 Apr;30(2):769-780. doi: 10.1007/s12350-022-03085-3. Epub 2022 Aug 15.
PMID: 35971031DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei Fang, MD/PhD
Fu Wai Hospital, Beijing, Chia
- PRINCIPAL INVESTIGATOR
Jianming Li, MD/PhD
TEDA International Cardiovascular Hospital
- PRINCIPAL INVESTIGATOR
Yuming Zheng, MD
China-Japanese Friendship Hospital, Beijing, China
- PRINCIPAL INVESTIGATOR
Jie Zhang, MD/MS
Central China Fuwai Hospital, Henan, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2018
First Posted
August 20, 2018
Study Start
May 3, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 2, 2022
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share