Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07004530

the MCCE vs EGD Trial

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Anaemia Acute Coronary Syndrome Anemia Cardiovascular Diseases Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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%)

Primary outcomes

  1. the occurrence of recurrent bleeding

    Time frame: baseline, 30 days

    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.

Secondary outcomes

  1. Need for any transfusion

    Time frame: baseline, 30 days

    Need for any transfusion

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

    Time frame: baseline, 30 days

    TIMI flow grade is a method used to assess coronary artery blood flow during and after thrombolytic therapy in patients with acute myocardial infarction. It's a standardized way to grade the degree of reperfusion, ranging from complete occlusion (Grade 0) to complete perfusion (Grade 3).

    BARC:

    Type 1: Minimal bleeding, not actionable. Type 2: Clinically evident but minor; requires treatment. Type 3: Significant bleeding, divided into 3A (moderate, requires transfusion), 3B (major, may need surgery), and 3C (critical, such as intracranial bleeding). Type 4: Bleeding related to CABG procedures.

  3. Change in Major adverse cardiac events

    Time frame: baseline, 30 days

    MACE as defined by death of cardiovascular origin, non-fatal myocardial infarction, non-fatal stroke, or clinically driven target vessel revascularization.

  4. Any adverse events and complications from MCCE and/or from EGD

    Time frame: baseline, 30 days

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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.