| NCT ID | NCT05669222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | ST-Segment Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2023-01-17 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The FAVOR V AMI study is a prospective, multicenter, blinded, randomized, sham-controlled trial comparing the long-term clinical outcomes of the "Functional and Angiography-derived Strain inTegration (FAST)" technique (next-generation quantitative flow ratio \[μQFR\] and radial wall strain \[RWS\]) guided percutaneous coronary intervention (PCI) strategy, with standard treatment strategy, in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary disease (MVD).
Eligibility Criteria
Inclusion Criteria: * General inclusion 1. Age ≥18 years 2. STEMI ≤30d 3. Successful primary PCI of all culprit lesion(s) responsible for the STEMI (visually-assessed residual stenosis \<30% in stent-treated lesions or \<50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in all treated vessels) 4. No MACE event between the index PCI and the staged randomized procedure 5. Able to understand the trial design and provide written informed consent * Angiographic inclusion: 1. The presence of at least 1 non-culprit lesion with DS% 50%-90% in any non-infarct related artery with RVD ≥2.5 mm by visual assessment 2. Non-culprit lesions are potentially eligible for PCI Note: All lesions in the infarct related arteries with DS ≥70% and RVD ≥2.5 mm by visual assessment must be successfully treated either during the index primary PCI or the staged procedure prior to randomization Note: There may also be 1 or more NCL with DS% \>90% (including a CTO) as long as there is at least 1 NCL with DS% 50%-90% as above. Any such lesions in which PCI is intended must be treated successfully either during the index primary PCI or the staged procedure prior to randomization. Exclusion Criteria: * General exclusion 1. Cardiogenic shock or refractory hypotension (Killip IV) 2. On pressors or use of or need for intra-aortic balloon pump or other mechanical circulatory support devices 3. Intubated 4. Prior thrombolytic therapy for this admission 5. Cockcroft-Gault-calculated CrCl \<30 ml/kg 6. Pregnant or woman of child-bearing potential 7. Life expectancy less than 1 year for non-cardiac causes 8. Allergy to iodine-containing contrast agents which cannot be adequately premedicated 9. Unable to tolerate DAPT for at least 6 months 10. Prior CABG or planned CABG 11. Any planned surgery within 6 months 12. Any condition that may interfere with any follow-up procedures (e.g. dementia, drug use) * Angiographic exclusion 1. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μQFR or RWS measurement 2. Unable to judge culprit lesion or infarct-related artery according to current evidence
Contact & Investigator
Bo Xu, MBBS
PRINCIPAL INVESTIGATOR
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen
Frequently Asked Questions
Who can join the NCT05669222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST-Segment Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05669222 currently recruiting?
Yes, NCT05669222 is actively recruiting participants. Contact the research team at bxu@citmd.com for enrollment information.
Where is the NCT05669222 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05669222 clinical trial?
NCT05669222 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Bo Xu, MBBS at Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen. The trial plans to enroll 5,000 participants.