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

January 27, 2015 updated by: Dandan Li

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart rate ≤70bpm
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 arrhythmia
Time Frame: During PCI
During PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean perioperative clinical heart rate
Time Frame: During PCI
The 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.
During PCI
Clinical resting heart rate and heart rate variability
Time Frame: During PCI
During PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dandan Li

Investigators

  • Principal Investigator: Yundai Chen, Ph.D., Ph.D. advisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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