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Could a balloon pump before angioplasty save more hearts?

NCT ID NCT07761455

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether starting a temporary balloon pump in the aorta before the standard artery-opening procedure (angioplasty) can improve outcomes for people who arrive at the hospital 4 to 12 hours after a major heart attack. Half of the participants will receive the balloon pump plus standard angioplasty, while the other half will receive angioplasty alone. The study tracks deaths, heart failure, and cardiogenic shock over 180 days to see if the extra support helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intra-aortic balloon pump (IABP) started before standard angioplasty
What this could lead to
If effective, this approach could reduce deaths, heart failure, and shock in people who arrive late after a major heart attack.
What could go wrong
The trial is still testing the idea, and the balloon pump carries risks like bleeding or vascular injury. Results may not apply to all heart attack patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 504 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years. 2. First electrocardiogram on arrival shows ST-segment elevation ≥ 2 mm in at least two contiguous anterior leads, or sum of ST-segment elevation ≥ 4 mm in anterior leads. 3. Ischemic symptoms (chest pain, chest tightness, upper abdominal discomfort, left shoulder radiation, etc.) onset to hospital arrival between ≥ 4 hours and ≤ 12 hours, and planned for primary PCI. 4. Coronary angiography confirms the infarct-related artery is the proximal left anterior descending (LAD) (before the first septal branch or first diagonal branch) with TIMI flow grade 0 (total occlusion). 5. Patient or legal representative provides written informed consent. Exclusion Criteria: 1. Established cardiogenic shock (systolic blood pressure \< 90 mmHg without inotropes/vasopressors, or requiring vasopressors to maintain systolic blood pressure ≥ 90 mmHg, AND blood lactate \> 2.0 mmol/L). 2. Severe heart failure: Killip class ≥ III, or requiring non-invasive/invasive positive pressure ventilation before enrollment. 3. Malignant arrhythmias, including cardiac arrest, ventricular fibrillation, ventricular flutter, pulseless ventricular tachycardia, or high-grade atrioventricular block. 4. Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation). 5. Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation). 6. Prior myocardial infarction or known chronic heart failure (left ventricular ejection fraction \< 50%). 7. Prior coronary artery bypass grafting (CABG). 8. Stroke within 1 month, or history of hemorrhagic stroke at any time. 9. Active gastrointestinal bleeding within 3 months, or gastrointestinal diseases with increased bleeding risk. 10. Received thrombolytic therapy for this episode. 11. Initiation of any mechanical circulatory support (IABP, Impella, ECMO) before coronary angiography. 12. Severe hepatic insufficiency (Child-Pugh C, or ALT \>5×ULN with total bilirubin \>3×ULN), renal insufficiency (eGFR \< 15 mL/min/1.73 m² or chronic dialysis), or end-stage disease with life expectancy \< 1 year. 13. Pregnancy or lactation. 14. Currently participating in another interventional trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, 100037, China

  • Jining No.1 People's Hospital

    Jining, Shandong, 272011, China

  • Qilu Hospital of Shandong University, Jinan, Shandong, China

    Jinan, Shandong, 250012, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

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Other studies related to the condition(s) this trial covers.