NCT07004530

the MCCE vs EGD Trial

Magnetically Controlled Capsule Endoscopy vs Esophago-gastro-Duodenoscopy as The Initial Investigation for Anaemia in Patients With Acute Coronary Syndrome (the MCCE vs EGD Trial) - a Single Centre Randomized Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Anaemia is common in patients with acute coronary syndrome (ACS) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (MACE). Esophageal-gastro-Duodenoscopy (EGD) is commonly used as an initial investigation for anaemia but is often non-diagnostic. Magnetically Controlled Capsule Endoscopy (MCCE) being less invasive and with comparable diagnostic accuracy as EGD, might be used as an alternative initial investigation for anaemia in patients with ACS.

Detailed description

Anaemia is common in patients with acute coronary syndrome (ACS) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (MACE). Esophageal-gastro-Duodenoscopy (EGD) is commonly used as an initial investigation for anaemia but is often non-diagnostic. Magnetically Controlled Capsule Endoscopy (MCCE) being less invasive and with comparable diagnostic accuracy as EGD, might be used as an alternative initial investigation for anaemia in patients with ACS.

Conditions

• Anaemia
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Magnetically Controlled Capsule Endoscopy (MCCE)	. The MCCE used in this study is the magnetically controlled capsule endoscopy (MCE, AnPx USA) which is a capsule measuring 28x12mm, and contains a permanent magnet inside its dome. Images are captured and recorded at 2 frames/s
PROCEDURE	Esophageal-gastro-Duodenoscopy (EGD)	Esophageal-gastro-Duodenoscopy (EGD) is commonly performed to look for source of bleeding in patients with anaemia. However, from our own analysis and from retrospective studies of EGD in patients with ACS, EGD finding was normal or non-significant in 20-80% patients14-16. Moreover, EGD was associated with non-negligible periprocedural risks in patients with ACS, including death directly attributed to EGD (9.1%; 95% CI 7.6-10.9%), hypotension (24.1%; 95% CI 17.0-32.9%), arrhythmias (8.3%; 95% CI 4.5-15.1%) and recurrent ACS (6.5%; 95% CI 3.2-12.8%)

Timeline

• Start date: 2025-09-24
• Primary completion: 2027-09-24
• Completion: 2027-11-24
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: Hong Kong