AnaemiaNCT07004530
the MCCE vs EGD Trial
A study testing Esophageal-gastro-Duodenoscopy (EGD) in people with Anaemia and Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anaemia, Acute Coronary Syndrome
- What is being tested?
- Esophageal-gastro-Duodenoscopy (EGD)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Sep 2025to 24 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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
- Being tested
- Magnetically Controlled Capsule Endoscopy (MCCE), Esophageal-gastro-Duodenoscopy (EGD)
- Keywords
- Capsule Endoscopy, Esophago-gastro-Duodenoscopy
- Medical subject headings
- Anemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically Controlled Capsule Endoscopy (MCCE)Procedure or surgery
. 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 or surgery
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%)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Esophageal-gastro-Duodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 30 days
Secondary outcomes (4)
Need for any transfusion
Need for any transfusion
Measured: baseline, 30 days
Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions
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.
Measured: baseline, 30 days
Change in Major adverse cardiac events
MACE as defined by death of cardiovascular origin, non-fatal myocardial infarction, non-fatal stroke, or clinically driven target vessel revascularization.
Measured: baseline, 30 days
Any adverse events and complications from MCCE and/or from EGD
Any adverse events and complications from MCCE and/or from EGD
Measured: baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start24 Sep 2025 (estimated)
- Primary completion24 Sep 2027 (estimated)
- Study completion24 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, GuangMing Tan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004530
- Sponsor's protocol ID
- 2024.237
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07004530
- Acronym / sponsor ID
- 2024.237
- Conditions
- Anaemia, Acute Coronary Syndrome
- Keywords
- Capsule Endoscopy, Esophago-gastro-Duodenoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 24 Sep 2025 (estimated)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCCE-first arm | Experimental | Procedure: Magnetically Controlled Capsule Endoscopy (MCCE)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 |
| EGD-first arm | Experimental | Procedure: Esophageal-gastro-Duodenoscopy (EGD)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | MCCE-first arm |
| 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%) | Procedure or surgery | EGD-first arm |
Primary outcome
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.
4 secondary outcomes
Need for any transfusion
Time frame: baseline, 30 days
Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions
Time frame: baseline, 30 days
Change in Major adverse cardiac events
Time frame: baseline, 30 days
Any adverse events and complications from MCCE and/or from EGD
Time frame: baseline, 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal-gastro-Duodenoscopy (EGD) in people with Anaemia and Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of recurrent bleeding (time frame: baseline, 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 2 Nov 2026.