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

Conditions

Myocardial Ischemia

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

Randomized multicenter studies have demonstrated the high accuracy of vasodilator stress cardiac magnetic resonance imaging (CMR) in detecting coronary stenoses and in estimating impaired flow reserve in coronary artery disease (CAD). Stress CMR has also been shown in many studies to be an effective cardiac prognosticating method for patients presenting with chest pain syndromes. The American College of Cardiology Foundation and American Heart Association have recommended stress CMR as an appropriate test for evaluation of symptomatic patients with intermediate to high pre-test probability for CAD. However, stress CMR remains an underutilized method in the United States. SPINS (Stress CMR Perfusion Imaging in the United States: A Society for Cardiovascular Resonance Registry Study) is a multicenter observational study of patients with stable chest pain syndromes designed to evaluate the long-term performance of stress CMR for cardiovascular prognosis and to investigate the cost of additional downstream cardiac testing following the index stress CMR.

Ge Y, Antiochos P, Bernhard B, Heydari B, Steel K, Bingham S, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Shanbhag SM, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY.

2024-10-162 citations

10.1016/j.jcmg.2024.07.029

Sex-Specific Stress Perfusion Cardiac Magnetic Resonance Imaging in Suspected Ischemic Heart Disease: Insights From SPINS Retrospective Registry.

Heydari B, Ge Y, Antiochos P, Islam S, Steel K, Bingham S, Abdullah S, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Shanbhag SM, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Raman SV, Ferrari VA, Shah DJ, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY.

2023-02-086 citations

10.1016/j.jcmg.2022.11.025

Prognostic Value of Stress Cardiac Magnetic Resonance in Patients With Known Coronary Artery Disease.

Antiochos P, Ge Y, Heydari B, Steel K, Bingham S, Abdullah SM, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY.

2021-08-1814 citations

10.1016/j.jcmg.2021.06.025

Prognostic Value of Stress CMR Perfusion Imaging in Patients With Reduced Left Ventricular Function

Yin Ge, Panagiotis Antiochos, Kevin Steel, Scott E. Bingham, Shuaib Abdullah et al. (23 authors)

JACC. Cardiovascular imaging2020-08-0529 citations

10.1016/j.jcmg.2020.05.034

Imaging of Clinically Unrecognized Myocardial Fibrosis in Patients With Suspected Coronary Artery Disease

Panagiotis Antiochos, Yin Ge, Kevin Steel, Scott E. Bingham, Shuaib Abdullah et al. (21 authors)

Journal of the American College of Cardiology2020-08-0157 citations

10.1016/j.jacc.2020.06.063

Cost-Effectiveness Analysis of Stress Cardiovascular Magnetic Resonance Imaging for Stable Chest Pain Syndromes.

Ge Y, Pandya A, Steel K, Bingham S, Jerosch-Herold M, Chen YY, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Hachamovitch R, Stuber M, Simonetti OP, Kwong RY.

2020-05-1362 citations

10.1016/j.jcmg.2020.02.029

Cardiac Magnetic Resonance Stress Perfusion Imaging for Evaluation of Patients With Chest Pain

Raymond Y. Kwong, Yin Ge, Kevin Steel, Scott E. Bingham, Shuaib Abdullah et al. (36 authors)

Journal of the American College of Cardiology2019-09-30243 citations

10.1016/j.jacc.2019.07.074

Interventions

DIAGNOSTIC_TESTStress 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 design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

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 left ventricular ejection fraction \<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)

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular Mortality	Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).	Patient mortality due to cardiac or vascular events
Acute Myocardial Infarction	Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).	Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period

Secondary

Measure	Time frame	Description
Cardiac Hospitalizations	Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).	Cardiac hospitalizations for unstable angina or worsened or new heart failure
Late Coronary Arterial Bypass Surgery	Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).	Coronary arterial bypass surgery beyond 6 months after cardiac magnetic resonance imaging
Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year	Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).	Healthcare costs spent for downstream cardiovascular testing after the cardiac magnetic resonance imaging study. The trade-offs between quality-adjusted life years and costs are evaluated using incremental cost-effectiveness analysis methods.

Countries

United States

Participant flow

Recruitment details

Consecutive patients who underwent a stress cardiac magnetic resonance (CMR) performed for assessment of stable chest pain syndromes or abnormal ECG between 1/1/2008 and 12/31/2013 were retrospectively identified. Their follow-up clinical outcome of at least 4 years after the date of stress CMR imaging study was collected between 12/1/2016 and 11/30/2019 and entered into a central SPINS registry database using standardized questions and data formats.

Pre-assignment details

Inclusion Criteria: all of the following at time of imaging: 1. male or female at age 35-85 years, 2. presence of either symptoms suspicious of ischemia, or abnormal electrocardiography with a suspicion of coronary artery disease 3. at least 2 of the following risk factors: patient age \> 50 for male, 60 for female, diabetes, hypertension, hypercholesterolemia, family history of premature coronary disease, Body mass index\> 30, peripheral artery disease, any hx of coronary artery disease.

Participants by arm

Arm	Count
Stress CMR and Stable Chest Pain Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.	2,349
Total	2,349

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	55

Baseline characteristics

Characteristic	Stress CMR and Stable Chest Pain	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	1164 Participants	—
Age, Categorical Between 18 and 65 years	1185 Participants	—
Age, Continuous	63 years STANDARD_DEVIATION 11	—
CAD Consortium Score, Basic	34 percentage	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	2349 participants	—
Sex: Female, Male Female	1104 Participants	—
Sex: Female, Male Male	1245 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	255 / 2,294
other Total, other adverse events	0 / 2,294
serious Total, serious adverse events	0 / 2,294

Outcome results

Primary

Acute Myocardial Infarction

Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period

Time frame: Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).