CONNECT Study

Not Applicable

Recruiting

• Conditions: Patients with acute myocardial infarction undergoing percutaneous coronary intervention; ischemic heart disease

• Registration Number: JPRN-jRCTs032180400
• Lead Sponsor: Taniwaki Masanori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age greater than or equal to 18 years
2. Primary PCI within 24 hours of symptom onset
3. ST-segment elevation of greater than or equal to 1mm in at least 2 contiguous leads, or (presumably new) left bundle branch block or true posterior MI with ST depression of greater than or equal to 1mm in at least 2 contiguous anterior leads
4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
5. Signed informed consent

Exclusion Criteria

1.Female of childbearing potential (age less than 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
2. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, biolimus or contrast material
3. Inability to provide informed consent
4. Currently participating in another trial before reaching first endpoint
5. Mechanical complications of acute myocardial infarction
6. Acute myocardial infarction secondary to stent thrombosis or restenosis
7. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
8. Noncardiac comorbid conditions are present with life expectancy less than 3 years or that may result in protocol noncompliance
9. History of bleeding diathesis or known coagulopathy
10. Use of oral anticoagulation
11. Age greater than or equal to 90 years
12. LV-function at index procedure less than or equal to 20%
13. Cancer under active treatment (chemotherapy)
14. Hemodynamic instability following primary PCI
15. Chronic kidney disease (estimated creatinine clearance less than 30ml/min)
16. OCT technically not feasible (severe calcification, tortuosity)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of neoatherosclerosis which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of greater than or equal to 1 mm in optical coherence tomography (OCT) at 3 years.