Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427749
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation

Brief Summary:
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.

Condition or disease
Coronary Artery Disease

Detailed Description:
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021



Primary Outcome Measures :
  1. Feasibility [ Time Frame: 2 years ]
    It is practical to obtain reliable SPECT measurements of MBF routinely within the workflow of a standard clinical practice

  2. MBF reproducibility [ Time Frame: 2 years ]
    Global MBF measured at remote sites will agree within 10% with the same data processed at an expert core laboratory.


Secondary Outcome Measures :
  1. Impact on throughput [ Time Frame: 2 Years ]
    Routine implementation of a SPECT MBF protocol will have at most minimal impact on patient throughput (defined as <10% reduction in patient volumes).

  2. Delayed imaging [ Time Frame: 2 years ]
    Static reconstruction of the last 6 min of the dynamic acquisition will provide images that are clinically equivalent (less than 10% change in patient diagnosis from normal (summed stress score < 4) to abnormal or vice versa), compared to standard static images obtained following a 45-min delay post-injection

  3. Half-dose MBF measurement [ Time Frame: 2 years ]
    The difference between MBF measurements with full-data and half-data dynamic acquisitions will be less than or equal to the inter-observer variation in MBF measurements with full-data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the local site, have known or suspected CAD and are deemed to clincally require MBF measurements.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • BMI ≤ 40 kg/m2
  • Able and willing to comply with the study procedures
  • Written informed consent
  • Intermediate to high probability of CAD
  • Suspected or known CAD on a stable medication regime

Exclusion Criteria:

  • History or risk of severe bradycardia (heart rate < 50 beats per minute) not related to chronotropic drugs
  • Known second- or third-degree AV block without pacemaker
  • Dyspnea (NYHA III/IV), wheezing asthma or COPD
  • Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or within 45 days after consent (early revascularization)
  • Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
  • Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427749


Contacts
Layout table for location contacts
Contact: Clare Carey, BScN 613-696-7000 ext 15103 ccarey@ottawaheart.ca
Contact: Terrence Ruddy, MD 613-696-7312 truddy@ottawaheart.ca

Locations
Layout table for location information
Belgium
Universitaire ziekenhuizen Leuven Not yet recruiting
Leuven, Belgium
Contact: Oliver Gheysens, MD         
Canada, Ontario
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Terrence Ruddy, MD    6136967312    truddy@ottawaheart.ca   
Contact: Clare Carey, Ontario    6136967000 ext 15103    ccarey@ottawaheart.ca   
Germany
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany
Contact: Frank Bengel, MD         
Japan
Ehime University Hospital Not yet recruiting
Toon, Japan
Contact: Masao Miyagawa, MD, PhD         
Singapore
National Heart Center Singapore Not yet recruiting
Singapore, Singapore, 169609
Contact: Keng Yung Jih Felix, MBBS, MRCH, MMed         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
GE Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Terrence Ruddy, MD Ottawa Heart Institute Research Corporation
Additional Information:

Layout table for additonal information
Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03427749    
Other Study ID Numbers: 20170797
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
Myocardial Blood Flow
SPECT
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases