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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
238
. 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) 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%)
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
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.
Time frame: baseline, 30 days
Need for any transfusion
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
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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline, 30 days