Clinical trial NCT07004530: the MCCE vs EGD Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anaemia
Acute Coronary Syndrome
Keywords: Capsule Endoscopy
Esophago-gastro-Duodenoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2025-06-04
Enrollment: 238
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

subjects are patients older than 18 years old with:

1. the diagnosis of ACS as defined by symptoms of chest pain or shortness-of-breath, abnormal electrocardiogram and positive enzyme, requiring coronary intervention
2. new-onset anaemia as defined by Hb\<11 g/dL on admission blood taking

Exclusion Criteria:

1. History of active haematological disease including hemoglobinopathies such as thalassemia, Myelodysplastic syndromes, haematological malignancy, aplastic anaemia, or autoimmune haemolytic anaemia.
2. Patients with known active gastrointestinal malignancy.
3. 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.
4. Contraindications for EGD: Possible gastrointestinal perforation, medically unstable patients, patient with known pharyngeal diverticulum, and patients with recent head and neck trauma.
5. 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.
6. Patients whose life-expectancy is less than 6 months.
7. Patients who are pregnant or lactating.
8. Patients who are unable to give informed consent.
9. Patients who are in active heart failure or fluid-overload state.
10. Patients who have chronic renal failure as defined by estimated glomerular filtration rate \<15 ml/min/1.73m2.

Primary outcomes:
measure: the occurrence of recurrent bleeding
timeFrame: baseline, 30 days
Secondary outcomes:
measure: Need for any transfusion
timeFrame: baseline, 30 days
measure: Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions
timeFrame: baseline, 30 days
measure: Change in Major adverse cardiac events
timeFrame: baseline, 30 days
measure: Any adverse events and complications from MCCE and/or from EGD
timeFrame: baseline, 30 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
References: