Initial CT Perfusion-Guided Strategy for Suspected NSTEMI
NCT ID: NCT06689267
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-01
2026-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Initial CT perfusion
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.
computed tomography myocardial perfusion
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 Angiography
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).
Invasive Coronary Angiography
Patients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed.
Interventions
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computed tomography myocardial perfusion
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 Angiography
Patients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed.
Eligibility Criteria
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Inclusion Criteria
2. No ST elevation or dynamic ST-T changes on the ECG
3. Elevated TNT (greater than 14 ng/L three hours after symptom onset)
Exclusion Criteria
2. Hemodynamic instability
3. Known history of coronary artery disease
4. Contraindications for CT perfusion or coronary angiography
5. Coexisting conditions such as pregnancy, cancer, severe valvular heart disease, or liver/kidney dysfunction
6. Other diseases with a life expectancy of less than one year
7. Inability to sign informed consent or, in the researcher's judgment, poor compliance, making it unlikely the patient can complete the study as required.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Junbo Ge
Director of the Department of Cardiology, Professor, Academician of the Chinese Academy of Sciences.
Principal Investigators
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Junbo Ge, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZS-SMART
Identifier Type: -
Identifier Source: org_study_id
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