An interventional study of Intra-Aortic Balloon Pump and Primary Percutaneous Coronary Intervention in Acute Anterior ST-Segment Elevation Myocardial Infarction, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
Among 146 studies in ST Elevation Myocardial Infarction with a site in China — 42 open to participants now, 44 under way, 2 of them phase 3. ST Elevation Myocardial Infarction · China.
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, this one is the 35th largest by planned enrollment of the 97 interventional ones, is one of 12 that started in 2026, is one of 51 with no phase, reaches primary completion later than 32 of the 42 other live ones, and was the 144th registered.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 504 is above the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →42 of the 146 studies in ST Elevation Myocardial Infarction with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 12 started in 2026.
Median enrollment 320 across the 97 interventional studies, 737 across the 48 observational. Of the 39 that completed or were terminated, 1 (3%) have results posted.
12 of 146 have an industry lead sponsor. The 10 most frequent:
Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Qilu Hospital of Shandong University has 2 studies filed under ST Elevation Myocardial Infarction — fewer than ten, so there is no comparison to draw.
17 of the studies in ST Elevation Myocardial Infarction with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT06794801LanZhou UniversityEvaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study | 2026-12 |
| NCT05967663RenJi HospitalFractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study) | 2026-12 |
| NCT06339021Shenyang Northern HospitalOCT or Angiography Guided De-escalation of DAPT | 2026-12-01 |
| NCT06548204Second Affiliated Hospital, Zhejiang University, School of MedicineEffect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial | 2026-12-30 |
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, from their registry updates:
PROACTIVE-AMI is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication evaluating whether prophylactic intra-aortic balloon counterpulsation (IABP) initiated before primary percutaneous coronary intervention (PPCI) improves clinical outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years who present 4 to 12 hours after symptom onset, have electrocardiographic evidence of anterior STEMI with proximal left anterior descending artery total occlusion (TIMI flow 0), and are planned for PPCI. Participants will be randomized 1:1 to pre-PPCI IABP plus standard PPCI or standard PPCI alone. The primary endpoint is 180-day major adverse cardiovascular events (MACE), defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary outcomes include individual MACE components, cardiac death, length of stay, NT-proBNP, left ventricular ejection fraction, and left ventricular end-diastolic volume. Safety outcomes include major bleeding, vascular complications, thrombocytopenia, and stroke.
This is a prospective, multicenter, randomized, open-label, parallel-group, controlled clinical trial with blinded endpoint adjudication. The study is designed to evaluate whether prophylactic intra-aortic balloon counterpulsation (IABP) before primary percutaneous coronary intervention (PPCI) can improve outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years with symptom onset to presentation between 4 and 12 hours, electrocardiographic evidence of anterior STEMI (≥2 mm ST elevation in contiguous anterior leads or sum ≥4 mm), and angiographically confirmed proximal left anterior descending artery occlusion with TIMI flow 0. After informed consent and coronary angiography confirming eligibility, participants are randomized in a 1:1 ratio to one of two groups: (1) prophylactic IABP before infarct-related artery opening plus standard PPCI, or (2) standard PPCI alone. In the intervention group, IABP will be inserted before PCI, operated at a 1:1 counterpulsation ratio for at least 24 hours and up to 72 hours as clinically appropriate. In the control group, prophylactic mechanical circulatory support will not be routinely used; rescue IABP may be initiated if predefined hemodynamic deterioration or complications occur. All participants receive guideline-directed medical therapy for ST-segment elevation myocardial infarction. The primary endpoint is major adverse cardiovascular events (MACE) within 180 days after randomization, defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary endpoints include individual components of the primary composite endpoint, cardiac death, length of hospital stay, NT-proBNP at 90 and 180 days, left ventricular ejection fraction and left ventricular end-diastolic volume at 90 and 180 days. Safety outcomes include major bleeding (BARC 3-5), vascular complications, thrombocytopenia, and stroke within 30 days. Follow-up assessments will be performed during hospitalization and at 30, 90, and 180 days after randomization. Endpoint adjudication will be performed by an independent clinical events committee blinded to treatment assignment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive prophylactic intra-aortic balloon pump counterpulsation before primary percutaneous coronary intervention (PPCI), followed by standard PPCI and guideline-directed medical therapy.
Device: Intra-Aortic Balloon Pump · Procedure: Primary Percutaneous Coronary Intervention
Participants randomized to this arm will receive standard PPCI and guideline-directed medical therapy without routine prophylactic IABP. Rescue IABP may be used only if clinically indicated according to protocol.
Procedure: Primary Percutaneous Coronary Intervention
Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.
Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.
180-day Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
Time frame: 180 days
All-cause Death
Death from any cause assessed at 180 days.
Time frame: 180 days
Cardiogenic Shock
Cardiogenic shock defined as systolic blood pressure \<90 mmHg without vasoactive support or requiring vasoactive agents to maintain blood pressure, together with blood lactate \>2.0 mmol/L, assessed at 180 days.
Time frame: 180 days
Heart Failure
New-onset or worsening heart failure during hospitalization or rehospitalization after discharge for heart failure, assessed at 180 days.
Time frame: 180 days
Cardiac Death
Death due to cardiovascular causes assessed at 180 days.
Time frame: 180 days
Length of Hospital Stay
Number of days from admission to discharge.
Time frame: from admission to discharge
NT-proBNP
Plasma NT-proBNP level at 90 days.
Time frame: 90 days
NT-proBNP
Plasma NT-proBNP level at 180 days.
Time frame: 180 days
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 90 days.
Time frame: 90 days
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 180 days.
Time frame: 180 days
Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 90 days.
Time frame: 90 days
Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 180 days.
Time frame: 180 days
Major Bleeding
Safety Outcome Measures: Bleeding events classified as BARC 3-5, assessed at 30 days.
Time frame: 30 days
Vascular Complications
Safety Outcome Measures: Severe vascular complications requiring surgical or endovascular repair, including limb ischemia, pseudoaneurysm, or arterial dissection, assessed at 30 days.
Time frame: 30 days
Thrombocytopenia
Safety Outcome Measures: Platelet count \<100 × 10\^9/L or a decrease of \>50% from baseline, assessed at 30 days.
Time frame: 30 days
Stroke
Safety Outcome Measures: Ischemic or hemorrhagic stroke adjudicated by the Clinical Events Committee, assessed at 30 days.
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) will not be shared because the study team does not currently have a data sharing plan or repository in place. De-identified participant-level data may be available from the corresponding author upon reasonable request and subject to institutional approval.
Start is estimated for Aug 2026; primary completion for Jan 2028, 17 months later.
Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 17 months is below that.
Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction →
Qilu Hospital of Shandong University →