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| Name | Class |
|---|---|
| Health and Medical Research Fund | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Need for any transfusion | Need for any transfusion | baseline, 30 days |
| Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions |
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Inclusion Criteria:
subjects are patients older than 18 years old with:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Shatin | 0000 | Hong Kong |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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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.
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| 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%) |
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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.
| 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. | 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 | baseline, 30 days |
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D013514 | Surgical Procedures, Operative |