the MCCE vs EGD Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetically Controlled Capsule Endoscopy (MCCE), Esophageal-gastro-Duodenoscopy (EGD).
- Who it may be relevant to
- Registry conditions: Anaemia, Acute Coronary Syndrome. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- the occurrence of recurrent bleeding [Time frame: baseline, 30 days]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT07004530 · 2024.237