Viable Myocardium Detected by Hybrid PET/MR and SPECT for the Prediction of the Efficacy of PCI iā¦ (NCT06113835) | Clinical Trial Compass
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Viable Myocardium Detected by Hybrid PET/MR and SPECT for the Prediction of the Efficacy of PCI in Patients With CTO.
China80 participantsStarted 2023-02-22
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Age ā§ 18 years, \< 75 years;
ā. complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ā„3 months;
ā. presence of angina or angina-equivalent symptoms ; undergo coronary intervention;
Exclusion criteria
ā. life expectancy \< 1 year due to non-cardiac disease;
ā. contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
ā. acute coronary syndrome within the last 3 months;
ā. severe valvular heart disease;
ā. haemodynamic instability;
ā. hepatic or renal insufficiency, with alanine aminotransferase (ALT) \> 3 times the upper limit of normal or glomerular filtration rate ā¤ 30 mL/min;
ā
What they're measuring
1
left ventricular ejection fraction increased by ā„5%
Timeframe: 6Ā±1 month
2
Segmental ventricular wall motion score decreased by ā„1
Timeframe: 6Ā±1 month
Trial details
NCT IDNCT06113835
SponsorThe First Affiliated Hospital with Nanjing Medical University