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Trial record 1 of 1 for:    NCT03192891
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Stress CMR Perfusion Imaging in the United States (SPINS) Study (SPINS)

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ClinicalTrials.gov Identifier: NCT03192891
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Siemens Healthcare
Bayer
Information provided by (Responsible Party):
Society for Cardiovascular Magnetic Resonance

Tracking Information
First Submitted Date June 16, 2017
First Posted Date June 20, 2017
Last Update Posted Date September 12, 2019
Actual Study Start Date March 1, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2017)
  • Mortality [ Time Frame: from time of study to the date 4 years following ]
    all-cause mortality
  • AMI [ Time Frame: from time of study to the date 4 years following ]
    Acute Myocardial Infarction
  • Late coronary revascularization [ Time Frame: from time of study to the date 4 years following ]
    PCI or CABG beyond 60 days after CMR
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 19, 2017)
  • Non-fatal cardiac events [ Time Frame: from time of study to the date 4 years following ]
    cardiac hospitalizations for unstable angina or heart failure, heart transplant, significant ventricular arrhythmias, and strokes
  • Cardiac event-weighted QALY [ Time Frame: from time of study to the date 4 years following ]
Original Secondary Outcome Measures
 (submitted: June 16, 2017)
  • Non-fatal cardiac events [ Time Frame: from time of study to the date 4 years following ]
    cardiac hospitalizations for unstable angina or heart failure, heart transplant, significant ventricular arrhythmias, and strokes
  • Alteration of diagnostic and therapeutic decision [ Time Frame: from time of study to the date 4 years following ]
  • Cardiac event-weighted QALY [ Time Frame: from time of study to the date 4 years following ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress CMR Perfusion Imaging in the United States (SPINS) Study
Official Title Stress CMR Perfusion Imaging in the United States (SPINS) Study. A Society for Cardiovascular Magnetic Resonance (SCMR) Registry Study
Brief Summary Numerous single-center studies have indicated gadolinium-enhanced stress CMR perfusion imaging has excellent diagnostic accuracy for coronary artery disease and negative clinical event rates, with its diagnostic accuracy exceeding nuclear scintigraphy. However, current prognostic evidence supporting clinical use of stress CMR is limited by study size, single-center settings with a predominance of academic centers, and a lack of "real-world" study design. Large-scale multicenter real-world evidence from a registry will provide the much needed information to guide evidence-based clinical adaptation that benefits patient care.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive patients who underwent stress CMR perfusion imaging for evaluation of myocardial ischemia between 2008-2013.
Condition Myocardial Ischemia
Intervention Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging
Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 16, 2017)
2200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2019
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

all of the following at time of imaging: a) male or female at age 35-85 years, b) presence of either of the following sign/symptom that led to stress CMR imaging

  1. Symptoms suspicious of ischemia, or
  2. abnormal ECG with a suspicion of coronary artery disease c) Intermediate or high risk of significant coronary disease based on at least 2 of the following conditions:

    1. patient age > 50 for male, 60 for female
    2. Diabetes: by either history or medical treatment
    3. Hypertension: by either history or medical treatment
    4. Hypercholesterolemia: by either history or medical treatment
    5. family history of premature coronary disease: first degree relative at age <= 55 male and <=65 female
    6. Body mass index > 30
    7. Any medical documentation of peripheral artery disease
    8. Any history of myocardial infarction or percutaneous coronary intervention

Exclusion Criteria:

  1. Prior history of coronary artery bypass surgery (CABG)
  2. Acute myocardial infarction within the past 30 days prior to CMR
  3. any significant non-coronary cardiac conditions confirmed by medical documentation a. severe valvular heart disease, b. non-ischemic cardiomyopathy with LVEF <40%, c. infiltrative cardiomyopathy, d. hypertrophic cardiomyopathy, e. pericardial disease with significant constriction, or
  4. active pregnancy,
  5. any competing conditions leading to an expected survival of < 2 years
  6. Known inability to follow-up due to logistical reasons (e.g. patient lives in another country where follow-up is not feasible)
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03192891
Other Study ID Numbers SCMR_GRANT_002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Society for Cardiovascular Magnetic Resonance
Study Sponsor Society for Cardiovascular Magnetic Resonance
Collaborators
  • Siemens Healthcare
  • Bayer
Investigators Not Provided
PRS Account Society for Cardiovascular Magnetic Resonance
Verification Date September 2019