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Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

A Single Centre, Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02351674
Enrollment
15000
Registered
2015-01-30
Start date
2015-01-31
Completion date
Unknown
Last updated
2015-01-30

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

Conditions

Coronary Heart Disease

Keywords

Heart Rate, Percutaneous coronary intervention, outcome

Brief summary

The trial is a single centre, retrospective cohort, non-interventional study to be conducted in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate the link between mean perioperative clinical heart rate and short-term composite outcomes during PCI among local CHD patients.

Detailed description

The study requires those data including subjects aged from 20 to 80 year-old, diagnosed as coronary heart disease with records on mean clinical heart rate during PCI from 2009.1 to 2014.5 in the database from the department of cardiology, Chinese PLA General Hospital, Beijing. All 15,000 subjects' related data from the database will be collected.Once selected, 15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean clinical resting heart rate during PCI. Group 1 will be defined as subjects' mean clinical resting heart rate ≤70 BPM, which will be set as baseline. Group 2 will be defined as subjects' mean clinical resting heart rate between 71 to 80 BPM. Group 3 will be defined as subjects' mean clinical resting heart rate between 81 to 90 BPM. Group 4 will be defined as subjects' mean clinical resting heart rate \>90 BPM. The primary endpoint is to determine the link between the mean perioperative heart rate and short-term outcomes during PCI among local CHD patients.

Interventions

None listed

Sponsors

Dandan Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients consecutive enrolled in Chinese PLA General Hospital from January 2009 to May 2014 * Diagnosed as coronary heart disease with records on mean clinical heart rate during PCI .

Exclusion criteria

* Inferior wall myocardial infarction (MI) history or/and acute inferior wall MI patients; * Dead within 3 days after admit into wards; * LVEF\<30%; * Install a permanent pacemaker patients.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmiaDuring PCI

Secondary

MeasureTime frameDescription
Mean perioperative clinical heart rateDuring PCIThe primary efficacy endpoint is proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmia.
Clinical resting heart rate and heart rate variabilityDuring PCI

Contacts

Primary ContactDandan Li, M.D.
ldd301heart@qq.com+86 10 55499135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026