Trial Outcomes & Findings for Stress CMR Perfusion Imaging in the United States (SPINS) Study (NCT NCT03192891)
NCT ID: NCT03192891
Last Updated: 2025-12-30
Results Overview
Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period
COMPLETED
2349 participants
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).
2025-12-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Retrospective Multicenter Cohort From 13 US Centers Referred to Stress CMR for Stable Chest Pain
Retrospective N=2,349 patients from 13 US centers referred for stress cardiac magnetic resonance imaging for evaluation of stable chest pain syndromes.
|
|---|---|
|
Overall Study
STARTED
|
2349
|
|
Overall Study
COMPLETED
|
2294
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Retrospective Multicenter Cohort From 13 US Centers Referred to Stress CMR for Stable Chest Pain
Retrospective N=2,349 patients from 13 US centers referred for stress cardiac magnetic resonance imaging for evaluation of stable chest pain syndromes.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
55
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stress CMR and Stable Chest Pain
n=2349 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1185 Participants
n=2349 Participants
|
|
Age, Categorical
>=65 years
|
1164 Participants
n=2349 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=2349 Participants
|
|
Sex: Female, Male
Female
|
1104 Participants
n=2349 Participants
|
|
Sex: Female, Male
Male
|
1245 Participants
n=2349 Participants
|
|
Region of Enrollment
United States
|
2349 participants
n=2349 Participants
|
|
CAD Consortium Score, Basic
|
34 percentage
n=2349 Participants
|
PRIMARY outcome
Timeframe: 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).Population: total cohort at risk
Patient mortality due to cardiac or vascular events
Outcome measures
| Measure |
Stress CMR and Stable Chest Pain
n=2294 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Cardiovascular Mortality
|
74 Participants
|
PRIMARY outcome
Timeframe: 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).Population: total cohort at risk
Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period
Outcome measures
| Measure |
Stress CMR and Stable Chest Pain
n=2294 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Acute Myocardial Infarction
|
77 Participants
|
SECONDARY outcome
Timeframe: 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).Population: total cohort at risk
Cardiac hospitalizations for unstable angina or worsened or new heart failure
Outcome measures
| Measure |
Stress CMR and Stable Chest Pain
n=2349 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Cardiac Hospitalizations
|
124 Participants
|
SECONDARY outcome
Timeframe: 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).Population: total cohort at risk
Coronary arterial bypass surgery beyond 6 months after cardiac magnetic resonance imaging
Outcome measures
| Measure |
Stress CMR and Stable Chest Pain
n=2294 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Late Coronary Arterial Bypass Surgery
|
44 Participants
|
SECONDARY outcome
Timeframe: 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).Population: total cohort at risk
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.
Outcome measures
| Measure |
Stress CMR and Stable Chest Pain
n=2294 Participants
Patients with chest pain syndromes suspicious for obstructive CAD who underwent stress CMR.
|
|---|---|
|
Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year
|
52000 Dollar/Quality-Adjusted Life Year
|
Adverse Events
Stress CMR and Stable Chest Pain
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place