A Prospective Evaluation of Clinical Impact of Physiology Versus Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI

NCT04996277 | Unknown DMC

• 1 other identifier: OCT-STEMI-2020
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study of physiologically functional FFR in STEMI patients without direct PCI treatment will provide unique data on plaque progression and risk factors.

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  These include cardiogenic death, target vascular-associated myocardial infarction, and ischaemic driven revascularization of target lesions

  1 year after baseline surgery

Secondary Outcomes (2)

• Major Adverse Cardiovascular Events

  1 year after baseline surgery

• Incidence of changes in treatment strategy in FFR and OCT patients

  1 year after baseline surgery

Study Arms (3)

Fractional Flow Reserve

EXPERIMENTAL

Patients with FFR ≤ 0.8 will undergo PCI Patients with FFR \> 0.8 will be treated with medication For study purposes, all patients will undergo OCT (subject's treatment strategy will be based on FFR results, e.g., stent-implanted OCT).

Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition

Optical CoherenceTomography

EXPERIMENTAL

Patients with MLA \< 4.5mm² will undergo PCI Other patients will be treated with medication For study purposes, all patients will undergo FFR (subject's treatment strategy is based on OCT results; reference to FFR results is not recommended)

Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition

angiography

EXPERIMENTAL

Appropriate treatment (implantation of stents) will be given according to the evaluation of the physician.

Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition

Interventions

angiography PROCEDURE

All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.

Fractional Flow Reserve; Optical CoherenceTomography; angiography

Thrombus suction PROCEDURE

All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.

Fractional Flow Reserve; Optical CoherenceTomography; angiography

Fibrinolytic therapy PROCEDURE

All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.

Fractional Flow Reserve; Optical CoherenceTomography; angiography

Medication stabilized the condition BEHAVIORAL

All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.

Fractional Flow Reserve; Optical CoherenceTomography; angiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≤ 18 ≤75;
• days after onset of STEMI;
• PCI was not performed for the following reasons:
• Stabilize the condition at a hospital that is unable to provide PCI and then refer to a tertiary hospital for further evaluation;
• Previous emergency angiography without balloon dilatation or stent implantation; Emergency thrombus aspiration without balloon dilation or stent placement;
• Patients with target lesion stenosis of 50%-90%, GRADE 3 TIMI blood flow and indications for stent implantation after receiving STEMI treatment in accordance with hospital standard procedures.

You may not qualify if:

• Left main disease or bypass disease;
• Intolerance to research drugs, metal alloys or contrast agents;
• Life expectancy is less than a year;
• PCI was performed on previous target vessels;
• Previous coronary artery bypass grafting;
• cardiogenic shock or LVEF\&lt; 35%;
• Severe renal or liver dysfunction;
• Hemodynamic instability;
• The degree of pathological stenosis of criminals was \> 90% or \< 50%;
• Target vessel TIMI blood flow ≤ grade 2;
• A surgical plan within 6 months after the initial operation;
• Had clinical indications of intolerance to 12-month DAPT therapy;
• Unable to provide written proof of informed consent;
• Patients who were enrolled in other clinical trials at the time of enrollment and did not meet the primary study endpoint.

Sponsors & Collaborators

• CCRF Inc., Beijing, China: lead
• Abbott Medical Devices: collaborator

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Cerebral Angiography; Thrombolytic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician/chief physician

Model Details: In this study, 300 subjects with target vessel stenosis of 50%-90% confirmed to be suitable for stent implantation by angiographic evaluation will be recruited and randomly assigned to FFR, OCT or Angio group according to 1:1:1. FFR group: Patients with FFR ≤0.8 were treated with PCI; FFR \&gt; 0.8 patients will receive drug therapy; All patients will undergo OCT examination. OCT group: if MLA\&lt; 4.5mm2 patients will receive PCI; Other patients will be treated with medication; All patients will be examined for FFR. Angio group: The appropriate treatment (stent implantation) will be given according to the evaluation of the doctor.

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 9, 2021
• Study Start: July 31, 2021
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2024
• Last Updated: August 9, 2021

Record last verified: 2021-08