Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT02784418
Status:
WITHDRAWN
Last Update Posted:
2021-06-07
First Post:
2016-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SHINE-CTO Trial
Sponsor:
Minneapolis Heart Institute Foundation
Organization:
Study Overview
Official Title:
SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding issues due to the pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE-CTO
Brief Summary:
Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.
Treatment:CTO PCI, as per standard clinical practice.
Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.
Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
Treatment:CTO PCI, as per standard clinical practice.
Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.
Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: