Evaluating a new method for assessing heart blood flow in STEMI patients

A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance in STEMI Patients (Flash IV)

This study is testing a new way to measure blood flow in the heart to see if it can help doctors better understand the long-term health of patients who have had a heart attack.

Quick facts

• Study type: Observational
• Enrollment: 335 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Locations: 8 sites (Beijing, Beijing and 7 other locations)
• Trial ID: NCT06118450 on ClinicalTrials.gov

What this trial studies

This observational trial aims to assess the safety and effectiveness of the coronary angiography-derived index of microvascular resistance (caIMR) in patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who have undergone primary percutaneous coronary intervention (PPCI). The study will measure caIMR immediately after the procedure and analyze its prognostic performance in relation to long-term outcomes. By utilizing a non-invasive approach, the trial seeks to provide insights into microvascular dysfunction and its implications for patient prognosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have been diagnosed with STEMI and have undergone primary PCI.

Not a fit: Patients with significant coronary artery disease requiring bypass surgery or those with severe renal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the assessment of heart blood flow in STEMI patients, leading to better management and outcomes.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Aged between 18 and 80, regardless of gender;
* Initially diagnosed as STEMI and underwent primary PCI;
* Voluntarily participated in this trial and signed the informed consent form.

Exclusion Criteria:

* Coronary angiography shows that PCI is not suitable;
* Past history of coronary artery bypass grafting (CABG);
* Past history of heart failure;
* Past history of myocardial infarction;
* Primary or secondary cardiomyopathy or heart valve disease;
* Patients with renal insufficiency (eGFR\<30ml/min (1.73m\^2)) or patients undergoing dialysis;
* Cardiogenic shock
* Persistent left or right coronary ostium lesion after target vessel PCI;
* Immediate effect of target vessel PCI is unsatisfactory \[such as thrombolysis in myocardial infarction (TIMI) flow \< grade 2, dissection that restricted blood flow, side branch occlusion (diameter\>1.5mm), exist distal embolism or angiographically visible thrombus\];
* Target vessel exist coronary fistula or myocardial bridge (lumen constriction \>50%);
* The target vessel cannot clearly expose the lesion in two positions with an included angle ≥ 30 degrees;
* Severe systemic infection
* Patients with malignant wasting disease, with an estimated survival of less than 1 year;
* The subject is participating in another clinical researches, and the primary endpoint has not been reached;
* The investigator believes that the subject has other conditions that are not suitable for clinical trials.

Where this trial is running

Beijing, Beijing and 7 other locations

• Beijing Luhe Hospital.Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• Peking University First Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Huai'an First People's Hospital — Huai'an, Jiangsu, China (Not_yet_recruiting)
• The First People'S Hospital of Lianyungang — Lianyungang, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• General Hospital of Xuzhou Mining Group — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Xuzhou First People's Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lu Yuan

Conditions Microvascular Coronary Artery Disease; STEMI; caIMR; coronary microvascular disease