Clinical trial NCT06113835: Viable Myocardium Detected by Hybrid PET/MR and SPECT for the Prediction of the Efficacy of PCI in Patients With CTO.
Official title: Viable Myocardium Detected by the Combination of Hybrid PET/MR and SPECT Imaging for the Prediction of the Efficacy of PCI in Patients With Chronic Total Occlusion.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: Chronic Total Occlusion of Coronary Artery
viable myocardium
Hybrid PET/MR and SPECT Imaging
Percutaneous coronary intervention
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with symptomatic coronary artery disease (CAD) (angina or angina equivalent) in the presence of a CTO of a relevant coronary artery

Brief summary: CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO.

In this investigator-initiated, prospective, single-center, observational trial, patients meeting the inclusion/exclusion criteria would be assigned to the successful group or the unsuccessful group based on the success of PCI, both undergoing pre-operative and 6-month follow-up Hybrid PET/MR and SPECT imaging. The improvement of left ventricular (LV) recovery after 6 months will be observed.

Detailed description: Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents a major challenge in interventional cardiology. However, the results of the current large-scale CTO study showed that PCI failed to improve the long-term prognosis (MACE) over medical therapy. Is CTO intervention necessary and how to select appropriate patients for intervention? Previous studies have found the presence and improvement of viable myocardium(VM) in patients with CTO after PCI，and the amount of preoperative VM is critical to the choice of treatment for patients.

Several diagnostic techniques have been introduced to assess myocardial viability and LV recovery, allowing the identification of ischemic myocardium with potentially reversible systolic dysfunction, such as hibernating myocardium, among which 2-deoxy-2-\[18F\]fluoro-D-glucose positron emission tomography ( 18F-FDG PET) as the "gold standard" for clinical assessment of VM. However, single FDG-PET assessment of VM has limitations and cannot accurately identify hibernating myocardium. 99mTc-Methoxyisobutylisocyanide single-photon emission computed tomography (99mTc-MIBI SPECT), as a validated method for assessing myocardial perfusion, is recommended by guidelines for the assessment of VM in combination with FDG-PET. In recent years, contrast-enhanced cardiac magnetic resonance imaging (cardiac magnetic resonance imaging CMR) has been increasingly used to assess myocardial viability due to its high spatial resolution, which allows the acquisition of cardiac function and myocardial scarring.

However, there are fundamental differences between the two methods in assessing VM and LV function, with LGE-CMR primarily describing an increase in extracellular space associated with scar tissue, whereas FDG-PET uptake represents the true metabolic signals of viable cardiomyocytes. They are complementary.

Hybrid PET/MRI has recently been used as a novel modality for evaluating cardiac diseases, allowing a truly synchronous/simultaneous acquisition of complementary information such as high-resolution anatomy and myocardial metabolism in merged images. However, few studies about PET/MRI were done in patients with CTO.

Our study aims to investigate the effect of CTO-PCI by assessing VM detected by the combination of PET/MR and SPECT and to investigate the predictive value of viable myocardial area on the efficacy of CTO-PCI.

Eligibility criteria: Inclusion Criteria:

1. Age ≧ 18 years, \< 75 years;
2. complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
3. presence of angina or angina-equivalent symptoms ; undergo coronary intervention;

Exclusion Criteria:

1. life expectancy \< 1 year due to non-cardiac disease;
2. contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
3. acute coronary syndrome within the last 3 months;
4. severe valvular heart disease;
5. haemodynamic instability;
6. hepatic or renal insufficiency, with alanine aminotransferase (ALT) \> 3 times the upper limit of normal or glomerular filtration rate ≤ 30 mL/min;
7. two or more CTO lesions;
8. previous myocardial infarction.
9. Others who, in the opinion o f the investigator, should not be enrolled;

Primary outcomes:
measure: left ventricular ejection fraction increased by ≥5%
timeFrame: 6±1 month
measure: Segmental ventricular wall motion score decreased by ≥1
timeFrame: 6±1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Study Principal Investigator
name: Chunjian Li, Dr,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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