FAPl Imaging Assessment of Revascularization Outcome in Ischemic Heart Failure
ConditionIschemic Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital
About this trial
Ischemic heart failure (IHF) is the final stage of coronary heart disease. Coronary revascularization is an important treatment method for IHF, but it has high perioperative risks and not all patients can benefit from it. Evaluation of viable myocardium is one of the important decision-making methods for IHF, but recent research results have raised doubts about its value. The clinical community urgently needs more precise and comprehensive non-invasive decision-making methods. Fibroblast activation protein inhibitor (FAPI) imaging can specifically identify activated fibroblasts and achieve non-invasive diagnosis of the early and reversible stage of myocardial injury. Previous studies have shown that FAPI imaging can identify more damaged myocardium in various heart diseases compared to existing imaging techniques, demonstrating good clinical application potential. This study aims to conduct a prospective cohort trial for IHF patients who have undergone revascularization, using 18F-FAPI and viable myocardium (18F-FDG) imaging to analyze the degree of improvement in left ventricular ejection fraction after revascularization and major adverse cardiovascular events, and to explore the independent or additive predictive value of 18F-FAPI imaging, in order to provide a more reliable non-invasive imaging decision-making method for the revascularization strategy of IHF patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
It meets the relevant standards for IHF as stipulated in the "2024 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure", and has a clear history of ischemic heart disease (such as previous myocardial infarction, history of revascularization, or confirmed coronary artery lesions by coronary angiography), and the echocardiogram shows that LVEF is ≤ 40%.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PCI (ercutaneous coronary intervention) and CABG (coronary artery bypass grafting, commonly known as heart bypass surgery)
Procedure/SurgeryThe intervention methods of PCI and CABG are the standard treatments prescribed by clinical doctors according to relevant guidelines. This study merely observes and records these treatments without influencing the clinical decisions.
Treatment groups
122 Participants
are divided into 1 treatment groupGroup A: IHF patients who are scheduled to receive revascularization treatment1 intervention
Trial outcomes
Primary outcomes
1
The absolute change in LVEF (ΔLVEF) from the baseline at 12 months after the surgery
Time frame
From the time of enrollment until 12 months after the surgerySecondary outcomes
1
The occurrence of major adverse cardiovascular events (MACE) within 12 months after the surgery
Including the composite endpoint of cardiac death, recurrent non-fatal myocardial infarction, and readmission due to heart failure
Time frame
From the time of enrollment until 12 months after the surgerySponsors and contacts
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Source ClinicalTrials.gov