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Unobtrusive Monitoring via a Non-contact Cardiorespiratory Recorder

A Study on Unobtrusive Arrhythmia Monitoring Based on a Non-contact Heart Rate and Respiration Recorder in Patients with Acute Myocardial Infarction Following Percutaneous Coronary Intervention (PCI)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129013
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

acute myocardial infarction, AMI

Interventions

Gold Standard:Holter monitor
Index test: non-contact heart rate and respiration recorder (i.e., a piezoelectric ceramic ballistocardiography [BCG] smart mattress)

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent form; 2. Commitment to follow the research procedures and cooperate throughout the entire study; 3. Age between 18 and 80; 4. Meet the diagnosis criteria for acute myocardial infarction: (1) Ischemic chest pain lasting >= 30 minutes; (2) Dynamic changes in ECG: ST-segment elevation myocardial infarction (STEMI): ST-segment elevation in 2 adjacent leads (V2-V3 >= 0.2 mV, other leads >= 0.1 mV); Non-ST-segment elevation myocardial infarction (NSTEMI): ST-segment depression >= 0.1 mV or T-wave inversion, positive troponin; (3) Elevated markers of myocardial injury: high-sensitivity troponin (hs-cTn) > 99th percentile of normal reference value; CK-MB >= 2 times the normal value; time from symptom onset to admission = 2 minutes overnight; (2) No ventricular tachycardia; (3) Occasional atrial or ventricular premature beats are allowed.

Exclusion criteria

Exclusion criteria: 1.Participants were excluded if they met any of the following criteria: (1) severe skin disease, allergic predisposition, or chest/back skin damage or infection that prevented proper placement of Holter electrodes or contact with the mattress; 2. known persistent arrhythmias, such as permanent atrial fibrillation or the presence of a cardiac pacemaker, which could confound the interpretation of the reference standard; 3.poor compliance, as determined by the study investigators, that might compromise completion of the study protocol; 4. any other circumstances that, in the investigators' judgment, rendered the participant inappropriate for study participation.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance: AUC, sensitivity, specificity, PPV, NPV, and 95% CI;

Countries

China

Contacts

Public ContactLi Nana

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

linana1203@hust.edu.cn+86 27 8572 6484

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026