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Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Completed
CT.gov ID
NCT03637725
Collaborator
(none)
221
Enrollment
4
Locations
32
Actual Duration (Months)
55.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and likely will further receive invasive coronary angiogram will be recruited for a SPECT MBF study. The MBF study will be performed as an adjunct to MPI utilizing the same rest and stress injections of 99mTc-Sestamibi (MIBI) tracer, and the same infusion of dipyridamole, adenosine or adenosine triphosphate for stressing. The MBF study will be completed in single or two days depending on the imaging protocol of MPI for a site. This is an observational study with no interventions to the clinical routine whatsoever. Three models of SPECT (GE NM530c) and SPECT/CT (Siemens Symbia-T16 and -T2) cameras are included to acquire rest/stress dynamic SPECT and MPI data. A CT scan will be acquired for the purpose of attenuation correction. All dynamic images will be reconstructed with physical corrections, including attenuation, scatter, resolution recovery and noise reduction, and processed to quantify MBF with the same kinetic modeling. The imaging processing of MBF study will be conducted with a SPECT MBF dedicated software (MyoFlowQ) in a central lab. MPI images will be collected and independently read by three consensus readers. The angiographic result will be independently reviewed by an interventional cardiologist. Diagnostic performance of SPECT MBF and perfusion will be compared utilizing angiographic result as the reference standard.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    221 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease
    Actual Study Start Date :
    May 3, 2018
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Coronary Artery Disease

    Suspected or known coronary artery disease

    Outcome Measures

    Primary Outcome Measures

    1. The diagnostic accuracy of MBF and MPI [Through the study completion up to 12 months]

      The diagnostic accuracy of MBF and MPI while angiography is utilized as the reference standard

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China-Japanese Friendship Hospital Beijing China
    2 Fuwai Hospital Beijing China
    3 Teda International Cardiovascular Hospital Tanjin China
    4 Central China Fuwai Hospital Zhengzhou China

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

    • Study Chair: Wei Fang, MD/PhD, Fu Wai Hospital, Beijing, Chia
    • Principal Investigator: Jianming Li, MD/PhD, Teda International Cardiovascular Hospital, Tianjin, China
    • Principal Investigator: Yuming Zheng, MD, China-Japanese Friendship Hospital, Beijing, China
    • Principal Investigator: Jie Zhang, MD/MS, Central China Fuwai Hospital, Henan, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT03637725
    Other Study ID Numbers:
    • SPECT MBFQ Trial I
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of Feb 2, 2022