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A randomized controlled trial comparing the efficacy of magnetically controlled capsule endoscopy with conventional treatment in high bleeding risk patients undergoing percutaneous coronary interventions for the prevention of gastrointestinal bleeding: the MACE-GPS study

A randomized controlled trial comparing the efficacy of magnetically controlled capsule endoscopy with conventional treatment in high bleeding risk patients undergoing percutaneous coronary interventions for the prevention of gastrointestinal bleeding: the MACE-GPS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070025
Enrollment
Unknown
Registered
2023-03-31
Start date
2023-04-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Capsule gastroscope group:Magnetically controlled capsule gastroscopy
Routine treatment group:Routine PCI treatment

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria 1.Eligible patients were at least 18 years old, undergoing cardiac catheterization +/- PCI for either chronic coronary syndrome or acute coronary syndrome with negative cardiac biomarkers (with a positive exercise electrocardiography or at least one severe (>= 70%) coronary artery stenosis diagnosed by invasive coronary angiography or coronary artery CT angiography); 2. In addition to meeting the main inclusion criteria, Subjects had to fulfill at least one of the following inclusion criteria: (1) Aged >= 75 years; (2) Previous history of peptic ulcer; (3) Previous history of gastrointestinal bleeding; (4) Hemoglobin < 11 g/dL; (5) Moderate, Severe or end-stage CKD, eGFR < 60 mL/min; (6) Anticipated use of long-term oral anticoagulation; (7) Liver cirrhosis with portal hypertension; (8) Active malignancy (excluding nonmelanoma skin cancer) within the past 12 month.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Patients need emergency percutaneous coronary intervention; 2. Patients with cardiogenic shock; 3. Patients with previous gastrointestinal or colonic surgery; 4. Coronary angiography confirmed coronary lesions not suitable for general percutaneous intervention; 5. Patients with left ventricular ejection fraction (LVEF) <= 35%; 6. Malignant tumours of the colon and rectum; 7. Platelet count < 100 x 10^9/L; 8. Severe haematological disorders; 9. Cerebral hemorrhage or subarachnoid hemorrhage; 10. History of bowel obstruction, bowel diverticulum; 11. Patients with pacemakers, cochlear implants, insulin pumps.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal bleeding;—

Secondary

MeasureTime frame
Major adverse cardiovascular events;—

Countries

China

Contacts

Public ContactYongjian Wu

Fuwai Hospital, Chinese Academy of Medical Sciences

wuyongjian@fuwaihospital.org+86 185 1057 9930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026