Non-ST Elevation Myocardial InfarctionSMARTNCT06689267
Initial CT Perfusion-Guided Strategy for Suspected NSTEMI
A study testing computed tomography myocardial perfusion and Invasive Coronary Angiography in people with Non-ST Elevation Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Non-ST elevation myocardial infarction (NSTEMI) is a relatively complex type of myocardial infarction, characterized by chest pain symptoms and elevated troponin levels. However, some patients initially diagnosed with suspected NSTEMI are found not to have severe stenosis upon coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction
- What is being tested?
- computed tomography myocardial perfusion and Invasive Coronary Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable chest tightness or chest pain, aged ≥18 years
- No ST elevation or dynamic ST-T changes on the ECG
- Elevated TNT (greater than 14 ng/L three hours after symptom onset)
Who cannot join
- Persistent chest pain or ECG indicating dynamic ST-T changes,
- Hemodynamic instability
- Known history of coronary artery disease
- Contraindications for CT perfusion or coronary angiography
- Coexisting conditions such as pregnancy, cancer, severe valvular heart disease, or liver/kidney dysfunction
- Other diseases with a life expectancy of less than one year
- Inability to sign informed consent or, in the researcher's judgment, poor compliance, making it unlikely the patient can complete the study as required.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Initial CT Perfusion-Guided Strategy Versus Invasive Coronary Angiography in Patients With Suspected Non-ST-Segment Elevation Myocardial Infarction
Non-ST elevation myocardial infarction (NSTEMI) is a relatively complex type of myocardial infarction, characterized by chest pain symptoms and elevated troponin levels. However, some patients initially diagnosed with suspected NSTEMI are found not to have severe stenosis upon coronary angiography. Recent studies have shown that initial imaging examinations (including CTA and CMR) in suspected NSTEMI patients can help reduce the need for coronary angiography. The diagnostic value of CT perfusion (CTP) has been established in patients with stable coronary artery disease, but relevant studies have not yet been conducted in suspected NSTEMI patients. This study aims to explore the diagnostic and therapeutic value of an initial CTP strategy for suspected NSTEMI patients. Additionally, we will conduct a cardiovascular health questionnaire to investigate the impact and prognostic value of factors such as adverse lifestyle and inflammation levels in these patients.
Read the detailed description
Acute myocardial infarction (AMI) is caused by acute and persistent ischemia and hypoxia of the coronary arteries, leading to myocardial necrosis. Clinically, it often presents as severe and prolonged retrosternal pain, accompanied by elevated serum myocardial enzyme levels and progressive changes in the electrocardiogram (ECG). Complications may include arrhythmias, shock, or heart failure, which can be life-threatening.
Non-ST elevation myocardial infarction (NSTEMI) is a more complex type of AMI. It presents with chest pain and elevated troponin levels, but without clear ischemic changes on the ECG, making clinical diagnosis challenging. Additionally, NSTEMI patients are highly heterogeneous, influenced by factors like lifestyle and inflammation. Current clinical guidelines recommend coronary angiography for these patients. However, previous studies have shown that approximately one-third of suspected NSTEMI patients do not exhibit significant coronary stenosis on angiography. Minimizing unnecessary invasive coronary angiography for such patients has become a pressing issue.
Recent clinical studies have explored the value of initial imaging tests in guiding treatment strategies for NSTEMI patients. The CARMENTA study found that performing CTA or MRI as the first-line test in suspected NSTEMI patients could reduce the need for subsequent invasive coronary angiography by 13% and 34%, respectively, and improve the positive detection rate on later angiography. The OxAMI study also showed that in patients with suspected NSTEMI who underwent MRI, only 67% had myocardial infarction, and even among those who subsequently underwent angiography and were found to have severe stenosis, CMR indicated infarction in only 84%. These findings suggest that while CTA can help rule out some myocardial infarction cases, its diagnostic value in suspected NSTEMI remains limited.
With advances in imaging technology, CT myocardial perfusion (CTP) has shown potential in more accurately identifying ischemic myocardium in coronary artery disease patients, thereby enhancing the diagnostic power of CTA. However, the diagnostic value of CTP for suspected NSTEMI patients remains unclear. Furthermore, technology now allows for simultaneous CTA and CTP testing without significantly increasing radiation exposure. This combined approach offers promise for more accurate diagnosis in suspected NSTEMI patients without a marked increase in radiation dose.
Therefore, this study aims to investigate the diagnostic and therapeutic value of an initial CTP strategy in suspected NSTEMI patients. Additionally, we will conduct a cardiovascular health questionnaire survey to explore the impact and prognostic value of adverse lifestyle factors and inflammation levels in these patients.
- Conditions
- Non-ST Elevation Myocardial Infarction
- Being tested
- computed tomography myocardial perfusion, Invasive Coronary Angiography
- Keywords
- NSTEMI, CT angiography, CT perfusion, invasive angiography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography myocardial perfusionDiagnostic test
The diagnostic value of CT perfusion (CTP) has been established in patients with stable coronary artery disease, but relevant studies have not yet been conducted in suspected NSTEMI patients. This study aims to explore the diagnostic and therapeutic value of an initial CTP strategy for suspected NSTEMI patients.
Invasive Coronary AngiographyProcedure or surgery
Patients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Initial CT perfusion | Experimental | Patients enrolled in the Initial CT perfusion group will first undergo CTA and CTP examinations. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or perform coronary angiography. Receives: Diagnostic Test: computed tomography myocardial perfusion |
| Invasive Coronary Angiography | Active comparator | Patients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or interventional treatment (including stent implantation or balloon angioplasty). Receives: Procedure: Invasive Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who ultimately undergo coronary angiography.
Patients enrolled in the Initial CT perfusion group will first undergo CTA and CTP examinations. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or coronary angiography. According to previous research data, approximately 20-30% of patients will not require coronary angiography. In contrast, patients enrolled in the Invasive Coronary Angiography group will undergo coronary angiography in 100% of cases.
Measured: From enrollment to 1 week or at the time of discharge from hospital, whichever came first
Secondary outcomes (1)
MACE
MACE was a composite of all- cause mortality, recurrent MI, unplanned coronary revascularization after the index event, or congestive heart failure requiring hospitalization.
Measured: From enrollment to the follow-up of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2024
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Junbo Ge, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689267
- Sponsor's protocol ID
- ZS-SMART
- Acronym
- SMART
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial CT Perfusion-Guided Strategy Versus Invasive Coronary Angiography in Patients With Suspected Non-ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06689267
- Acronym / sponsor ID
- SMART / ZS-SMART
- Conditions
- Non-ST Elevation Myocardial Infarction
- Keywords
- NSTEMI, CT angiography, CT perfusion, invasive angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-ST elevation myocardial infarction (NSTEMI) is a relatively complex type of myocardial infarction, characterized by chest pain symptoms and elevated troponin levels. However, some patients initially diagnosed with suspected NSTEMI are found not to have severe stenosis upon coronary angiography. Recent studies have shown that initial imaging examinations (including CTA and CMR) in suspected NSTEMI patients can help reduce the need for coronary angiography. The diagnostic value of CT perfusion (CTP) has been established in patients with stable coronary artery disease, but relevant studies have not yet been conducted in suspected NSTEMI patients. This study aims to explore the diagnostic and therapeutic value of an initial CTP strategy for suspected NSTEMI patients. Additionally, we will conduct a cardiovascular health questionnaire to investigate the impact and prognostic value of factors such as adverse lifestyle and inflammation levels in these patients.
Detailed description
Acute myocardial infarction (AMI) is caused by acute and persistent ischemia and hypoxia of the coronary arteries, leading to myocardial necrosis. Clinically, it often presents as severe and prolonged retrosternal pain, accompanied by elevated serum myocardial enzyme levels and progressive changes in the electrocardiogram (ECG). Complications may include arrhythmias, shock, or heart failure, which can be life-threatening.
Non-ST elevation myocardial infarction (NSTEMI) is a more complex type of AMI. It presents with chest pain and elevated troponin levels, but without clear ischemic changes on the ECG, making clinical diagnosis challenging. Additionally, NSTEMI patients are highly heterogeneous, influenced by factors like lifestyle and inflammation. Current clinical guidelines recommend coronary angiography for these patients. However, previous studies have shown that approximately one-third of suspected NSTEMI patients do not exhibit significant coronary stenosis on angiography. Minimizing unnecessary invasive coronary angiography for such patients has become a pressing issue.
Recent clinical studies have explored the value of initial imaging tests in guiding treatment strategies for NSTEMI patients. The CARMENTA study found that performing CTA or MRI as the first-line test in suspected NSTEMI patients could reduce the need for subsequent invasive coronary angiography by 13% and 34%, respectively, and improve the positive detection rate on later angiography. The OxAMI study also showed that in patients with suspected NSTEMI who underwent MRI, only 67% had myocardial infarction, and even among those who subsequently underwent angiography and were found to have severe stenosis, CMR indicated infarction in only 84%. These findings suggest that while CTA can help rule out some myocardial infarction cases, its diagnostic value in suspected NSTEMI remains limited.
With advances in imaging technology, CT myocardial perfusion (CTP) has shown potential in more accurately identifying ischemic myocardium in coronary artery disease patients, thereby enhancing the diagnostic power of CTA. However, the diagnostic value of CTP for suspected NSTEMI patients remains unclear. Furthermore, technology now allows for simultaneous CTA and CTP testing without significantly increasing radiation exposure. This combined approach offers promise for more accurate diagnosis in suspected NSTEMI patients without a marked increase in radiation dose.
Therefore, this study aims to investigate the diagnostic and therapeutic value of an initial CTP strategy in suspected NSTEMI patients. Additionally, we will conduct a cardiovascular health questionnaire survey to explore the impact and prognostic value of adverse lifestyle factors and inflammation levels in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial CT perfusion | Experimental | Diagnostic Test: computed tomography myocardial perfusionPatients enrolled in the Initial CT perfusion group will first undergo CTA and CTP examinations. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or perform coronary angiography. |
| Invasive Coronary Angiography | Active comparator | Procedure: Invasive Coronary AngiographyPatients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or interventional treatment (including stent implantation or balloon angioplasty). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stable chest tightness or chest pain, aged ≥18 years
- No ST elevation or dynamic ST-T changes on the ECG
- Elevated TNT (greater than 14 ng/L three hours after symptom onset)
Key exclusion criteria (7 listed)
- Persistent chest pain or ECG indicating dynamic ST-T changes,
- Hemodynamic instability
- Known history of coronary artery disease
- Contraindications for CT perfusion or coronary angiography
- Coexisting conditions such as pregnancy, cancer, severe valvular heart disease, or liver/kidney dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography myocardial perfusionThe diagnostic value of CT perfusion (CTP) has been established in patients with stable coronary artery disease, but relevant studies have not yet been conducted in suspected NSTEMI patients. This study aims to explore the diagnostic and therapeutic value of an initial CTP strategy for suspected NSTEMI patients. | Diagnostic test | Initial CT perfusion |
| Invasive Coronary AngiographyPatients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed. | Procedure or surgery | Invasive Coronary Angiography |
Primary outcome
The proportion of patients who ultimately undergo coronary angiography.
Time frame: From enrollment to 1 week or at the time of discharge from hospital, whichever came first
Patients enrolled in the Initial CT perfusion group will first undergo CTA and CTP examinations. Based on the results of these tests, the treatment team will then decide whether to proceed with conservative medical therapy or coronary angiography. According to previous research data, approximately 20-30% of patients will not require coronary angiography. In contrast, patients enrolled in the Invasive Coronary Angiography group will undergo coronary angiography in 100% of cases.
1 secondary outcome
MACE
Time frame: From enrollment to the follow-up of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography myocardial perfusion and Invasive Coronary Angiography in people with Non-ST Elevation Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who ultimately undergo coronary angiography. (time frame: From enrollment to 1 week or at the time of discharge from hospital, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.