NCT06820970

CRIC Combined With MFT for Cardiovascular Adverse Events in Patients With Incomplete Revascularization of CAD

Chronic Remote Ischemic Conditioning Combined With Mindfulness Therapy for Cardiovascular Adverse Events in Patients With Incomplete Revascularization of Coronary Artery Disease: A Multicenter, Double-blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can reduce cardiovascular adverse events in patients with incomplete revascularization of coronary artery disease.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	chronic remote ischemic conditioning	Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is squeezed for 6 minutes per cycle and the rest is 4 minutes, for a total of 4 cycles per cycle.
BEHAVIORAL	Mindfulness Therapy	Participants receive guided mindfulness audio sessions twice daily for \~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality.
OTHER	sham CRIC	The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group.
BEHAVIORAL	sham MFT	Sham MFT: Health Education + Relaxation (HER): A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation (music or simple muscle loosening), excluding mindfulness-specific techniques (no present-moment/nonjudgmental awareness training, no breath-focused meditation, no open monitoring).

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-01-01
• Completion: 2029-12-30
• First posted: 2025-02-11
• Last updated: 2026-04-06

Locations

1 site across 1 country: China