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Effect of Staged Remote Ischemic Conditioning on Cardiopulmonary Functional Recovery Trajectories After PCI in Patients With Angina: A Randomized Parallel-Controlled PROBE Study

Effect of Staged Remote Ischemic Conditioning on Cardiopulmonary Functional Recovery Trajectories After PCI in Patients With Angina: A Randomized Parallel-Controlled PROBE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121093
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

self-funding

Interventions

Intervention group:Receive staged remote ischemic conditioning (RIC) intervention on the basis of conventional treatment
Control Group:Only guideline-directed standard therapy (GDMT) and routine PCI perioperative management are accepted

Sponsors

People's Hospital of Jiang'an County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–75 years, no gender restriction; 2. Hospitalized for stable angina or unstable angina, with coronary angiography confirming significant coronary artery stenosis requiring revascularization, and scheduled for elective or urgent percutaneous coronary intervention (PCI); the targeted lesion/target vessel PCI for this planned intervention should be successful (residual stenosis =45%); 5. Planned to undergo cardiopulmonary exercise testing (CPET) on postoperative day 7 ± 2 and at 3 months postoperatively; before each CPET, reassessed by a research physician according to exercise testing safety standards to confirm no clear absolute contraindications and the ability to complete the test; 6. Expected to complete the 3-month postoperative follow-up; 7. Able to understand the purpose and procedures of the study, voluntarily participate, and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Disease-Related Exclusion Individuals meeting any of the following conditions will not be included in this study: (1) Patients with acute myocardial infarction, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI); (2) Patients with acute coronary syndrome requiring emergency percutaneous coronary intervention (PCI); (3) Patients with severe hemodynamic instability or persistent ischemic conditions during the perioperative period, including but not limited to cardiogenic shock, persistent hypotension (requiring vasopressor support), or recurrent/persistent chest pain; (4) Patients with uncontrolled severe arrhythmias, including but not limited to persistent ventricular tachycardia, ventricular fibrillation, rapid atrial fibrillation with hemodynamic instability, or high-degree atrioventricular block; (5) Patients with a confirmed diagnosis of ischemic cardiomyopathy or significant left ventricular systolic dysfunction (LVEF 180 mmHg or diastolic BP >110 mmHg); (4) Severe respiratory, neurological, or musculoskeletal disorders that significantly limit exercise capacity making CPET completion impossible; (5) Other conditions deemed unsuitable for CPET by the study physician. 3. Exclusion Criteria Related to RIC Implementation Participants meeting any of the following conditions will not be included in this study: (1) Upper limbs unsuitable for remote ischemic conditioning (RIC), such as severe peripheral vascular disease, thrombosis, infection, deformities, or recent upper limb surgery, etc. 4. Other Exclusion Criteria Participants meeting any of the following conditions will not be included in this study: (1) Recent participation in other interventional clinical studies that may affect the study results; (2) Severe liver or kidney dysfunction, malignant tumors, or other serious systemic diseases with a short expected survival; (3) Non-cardiac diseases that significantly limit exercise capacity, such as moderate to severe anemia, symptomatic peripheral arterial disease, or obvious frailty; (4) Cognitive impairment or inability to comply with study procedures; (5) Pregnant or breastfeeding women; (6) Individuals expected to be unable to complete follow-up or with poor compliance; (7) Recent severe infection, major surgery, acute cerebrovascular events, or other conditions that may significantly affect short-term exercise tolerance recovery; (8) Oth

Design outcomes

Primary

MeasureTime frame
VO2max / VO2peak ;

Secondary

MeasureTime frame
Cardiac enzyme profile;Index of Microcirculatory Resistance (IMR, derived from QFR);Metabolic equivalents (METs) measured by CPET;Six-minute walk distance;Left ventricular ejection fraction;Left ventricular diastolic function;N-terminal pro-B-type natriuretic peptide;Carotid–femoral pulse wave velocity;Nitric oxide;Superoxide dismutase (SOD);Interleukin-6 (IL-6);Interleukin-10 (IL-10);Seattle Angina Questionnaire (SAQ);Patient Health Questionnaire-9 (PHQ-9) Score;Generalized Anxiety Disorder-7 (GAD-7) Score;

Countries

China

Contacts

Public ContactChang Cheng

People's Hospital of Jiang'an County

937449609@qq.com+86 159 8310 3603

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026