BridgeMD
New treatment option for Acute Myocardial Infarction (AMI)
Official title Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)
ClinicalTrials.gov ID: NCT07567625
What this study is testing
What is Guideline-recommended standard medical therapy alone?
Guideline-recommended standard medical therapy alone is an investigational medicine, being studied as a potential treatment for acute myocardial infarction (ami).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (\<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female patients aged ≥18 years and ≤75 years;
- Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI;
- After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes...
- Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm;
- Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
You likely can't join if
- 1.Clinical exclusion criteria:
- Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%;
- Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
- Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
- Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
- Contraindication to contrast;
See the full eligibility criteria
- Male or female patients aged ≥18 years and ≤75 years;
- Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI;
- After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) \<70% at the culprit lesion (QCA);
- Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm;
- Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
- 1.Clinical exclusion criteria:
- Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%;
- Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
- Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
- Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
- Contraindication to contrast;
- Severe renal dysfunction [defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);
- Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST \>3× upper limit of normal (ULN);
- Previous history of CABG or PCI for the culprit lesion;
- Patients with other concurrent severe diseases and an expected life expectancy of \<1 year;
- Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
- Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator. 2.Imaging exclusion criteria:
- Non-culprit lesion with DS ≥70% or planned revascularization;
- Left main coronary artery lesion with DS ≥50%;
- Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
- Long lesion (planned stent length \>60 mm);
- Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
- Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.). 3.Functional sub study:
- Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
- Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
- Patients with bronchial asthma.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Beijing, China
- Cangzhou, China
- Chengde, China
- Chengdu, China
- Dalian, China
- Daqing, China
- Harbin, China
- Hunan, China
- Jiamusi, China
- Jilin City, China
- Jinan, China
- Jining, China
- Lanzhou, China
- Linyi, China
- Mudanjiang, China
- Nanyang, China
- Qingdao, China
- Qiqihar, China
- Shenyang, China
+ 12 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China; Beijing, China; Cangzhou, China; Chengde, China; Chengdu, China; Dalian, China and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.