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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital
  • Beijing, China
    • China-Japanese Friendship Hospital
  • Tanjin, China
    • TEDA International Cardiovascular Hospital
  • Zhengzhou, China
    • Central China Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coronary Artery Disease; Suspected or known coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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. 2022 Aug 15. doi: 10.1007/s12350-022-03085-3. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SPECT MBFQ Trial I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No