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

Dandan Li

Status: Unknown

Conditions: Coronary Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02351674

ESR-14-10413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

15,000 participants in 4 patient groups

Heart rate ≤70bpm

Description:

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 1 will be defined as subjects' mean heart rate ≤70 BPM.

Heart rate between 71 to 80bpm

Description:

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 2 will be defined as subjects' mean heart rate between 71 to 80bpm.

Heart rate between 81 to 90bpm

Description:

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 1 will be defined as subjects' mean heart rate between 81 to 90bpm.

Heart rate>90bpm

Description:

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 4 will be defined as subjects' mean heart rate\>90bpm