the MCCE vs EGD Trial

NCT07004530 | Not Yet Recruiting

• 1 other identifier: 2024.237
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaemia; Acute Coronary Syndrome

Keywords

Capsule Endoscopy; Esophago-gastro-Duodenoscopy

Outcome Measures

Primary Outcomes (1)

• the occurrence of recurrent bleeding

  A bleeding event will be defined according to international consensus by the occurrence of any of the followings: 1) overt bleeding of gastroduodenal origin including fresh hematemesis, bloody nasogastric aspiration, melena after normalization of stool colour, or haematochezia after normalization of stool colour, or 2) bleeding of presumed occult gastrointestinal origin with a documented reduction in haemoglobin concentration of ≥2 g/dl or reduction in the haematocrit by 10% or more from the baseline.

  baseline, 30 days

Secondary Outcomes (4)

• Need for any transfusion

  baseline, 30 days

• Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions

  baseline, 30 days

• Change in Major adverse cardiac events

  baseline, 30 days

• Any adverse events and complications from MCCE and/or from EGD

  baseline, 30 days

Study Arms (2)

MCCE-first arm

EXPERIMENTAL

MCCE will be performed for individuals randomized to MCCE arm within the same hospitalization of ACS diagnosis. 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. Before the MCCE procedure, subjects will be fasted for 8 hours. Capsule will be swallowed with 10ml of clear liquid. During the MCCE examination, subjects will be asked to drink 500 to 1000ml water on demand. Once inside the stomach, the capsule will be navigated via an external magnetic guidance system to obtain a full view of the stomach. After the gastric examination, the subject wears a portable image recorder for images of duodenum and the rest of the small bowel for about 4 hours

Procedure: Magnetically Controlled Capsule Endoscopy (MCCE)

EGD-first arm

EXPERIMENTAL

Conventional EGD with intravenous sedation will be performed for individuals randomized to EGD arm within the same hospitalization of ACS diagnosis by an experienced endoscopist. Similar MLD and Forest ulcer grading will be applied as in MCCE arm. Endoscopic therapeutic procedures will be performed at endoscopist's discretion.

Procedure: Esophageal-gastro-Duodenoscopy (EGD)

Interventions

Magnetically Controlled Capsule Endoscopy (MCCE) PROCEDURE

. 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

MCCE-first arm

Esophageal-gastro-Duodenoscopy (EGD) PROCEDURE

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%)

EGD-first arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects are patients older than 18 years old with:
• the diagnosis of ACS as defined by symptoms of chest pain or shortness-of-breath, abnormal electrocardiogram and positive enzyme, requiring coronary intervention
• new-onset anaemia as defined by Hb\<11 g/dL on admission blood taking

You may not qualify if:

• History of active haematological disease including hemoglobinopathies such as thalassemia, Myelodysplastic syndromes, haematological malignancy, aplastic anaemia, or autoimmune haemolytic anaemia.
• Patients with known active gastrointestinal malignancy.
• Contraindications for CE: suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required; history of laparotomy, gastric or bowel surgery; presence of metallic implants that is not MRI conditional.
• Contraindications for EGD: Possible gastrointestinal perforation, medically unstable patients, patient with known pharyngeal diverticulum, and patients with recent head and neck trauma.
• Inability to take 1-month DAPT such as non-deferrable surgery within 1 months, severe allergy or hypersensitivity reaction to aspirin or P2Y12 inhibitors, or patients in whom 1 months DAPT is not indicated.
• Patients whose life-expectancy is less than 6 months.
• Patients who are pregnant or lactating.
• Patients who are unable to give informed consent.
• Patients who are in active heart failure or fluid-overload state.
• Patients who have chronic renal failure as defined by estimated glomerular filtration rate \<15 ml/min/1.73m2.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

Location

MeSH Terms

Conditions

Anemia; Acute Coronary Syndrome

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients meeting eligibility criteria will be randomized by one of the research team staff via sealed envelopes with computer generated randomization number to one of the two study arms (0 for EGD, 1 for CE) in a 1:1 ratio, according to a central randomization scheme. Due to the nature of the interventions, researchers and patients are not blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): November 24, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

HK (1)