Stress CMR Perfusion Imaging in the United States (SPINS) Study

Myocardial Ischemia Clinical Trial

— SPINS  

Official title:

Stress CMR Perfusion Imaging in the United States (SPINS) Study. A Society for Cardiovascular Magnetic Resonance (SCMR) Registry Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03192891
• Other study ID #: SCMR_GRANT_002
• Status: Active, not recruiting
• Start date: March 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: September 2019
• Source: Society for Cardiovascular Magnetic Resonance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2200
• Est. completion date: November 30, 2019
• Est. primary completion date: March 31, 2018
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• 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.

Locations

Country	Name	City	State
United States	National Heart, Lung, and Blood Institute (NHLBI)	Bethesda	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Sharon Regional Health System	Hermitage	Pennsylvania
United States	Houston Methodist	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Revere Health	Provo	Utah
United States	San Antonio Military Medical Center - Wilford Hall	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Society for Cardiovascular Magnetic Resonance	Bayer, Siemens Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	all-cause mortality	from time of study to the date 4 years following
Primary	AMI	Acute Myocardial Infarction	from time of study to the date 4 years following
Primary	Late coronary revascularization	PCI or CABG beyond 60 days after CMR	from time of study to the date 4 years following
Secondary	Non-fatal cardiac events	cardiac hospitalizations for unstable angina or heart failure, heart transplant, significant ventricular arrhythmias, and strokes	from time of study to the date 4 years following
Secondary	Cardiac event-weighted QALY		from time of study to the date 4 years following