Assessing heart muscle viability to improve PCI outcomes in patients with blocked arteries
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.
This study is testing if special heart imaging can help doctors find healthy heart muscle in patients with blocked arteries to see if it improves the success of a procedure called PCI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06113835 on ClinicalTrials.gov |
What this trial studies
This observational trial investigates the role of hybrid PET/MR and SPECT imaging in identifying viable myocardium in patients with chronic total occlusion (CTO) of coronary arteries. Patients will undergo pre-operative imaging and follow-up assessments at six months to evaluate the effectiveness of percutaneous coronary intervention (PCI) based on the presence of viable myocardium. The study aims to determine if the detection of viable myocardium can enhance the success rates of PCI and improve left ventricular recovery. By analyzing the outcomes of patients categorized into successful and unsuccessful PCI groups, the trial seeks to provide insights into optimal patient selection for CTO interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic total occlusion of a coronary artery and symptoms of angina.
Not a fit: Patients with life expectancy under one year due to non-cardiac diseases or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing PCI by better identifying those who would benefit from the procedure.
How similar studies have performed: While the approach of using hybrid imaging techniques is promising, the specific combination of methods in this study has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Nanjing, Jiangsu
- First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Chunjian Li, Dr,PhD — Study Principal Investigator
- Study coordinator: Chunjian Li, Dr,PhD
- Email: drcjli@hotmail.com
- Phone: +86-13701465229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.