Initial CT Perfusion-Guided Strategy for Suspected NSTEMI

NCT06689267 | Completed DMC

• 1 other identifier: ZS-SMART
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non-ST Elevation Myocardial Infarction

Keywords

NSTEMI; CT angiography; CT perfusion; invasive angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 1 week or at the time of discharge from hospital, whichever came first

Secondary Outcomes (1)

• MACE

  From enrollment to the follow-up of 1 year

Other Outcomes (1)

• Perioperative adverse events

  From enrollment to the follow-up of 1 year

Study Arms (2)

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.

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).

Procedure: Invasive Coronary Angiography

Interventions

Invasive Coronary Angiography PROCEDURE

Patients enrolled in the Invasive Coronary Angiography group will directly undergo coronary angiography. If necessary, intracoronary imaging (including IVUS and OCT) will be performed.

Invasive Coronary Angiography

computed tomography myocardial perfusion DIAGNOSTIC_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.

Initial CT perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Junbo Ge, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology, Professor, Academician of the Chinese Academy of Sciences.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 3, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)