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

NCT ID: NCT02351674

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Keywords

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Heart Rate Percutaneous coronary intervention outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dandan Li

OTHER

Sponsor Role lead

Responsible Party

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Dandan Li

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yundai Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ph.D. advisor

Central Contacts

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Dandan Li, M.D.

Role: CONTACT

Phone: +86 10 55499135

Email: [email protected]

References

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Fox K, Borer JS, Camm AJ, Danchin N, Ferrari R, Lopez Sendon JL, Steg PG, Tardif JC, Tavazzi L, Tendera M; Heart Rate Working Group. Resting heart rate in cardiovascular disease. J Am Coll Cardiol. 2007 Aug 28;50(9):823-30. doi: 10.1016/j.jacc.2007.04.079. Epub 2007 Aug 13.

Reference Type BACKGROUND
PMID: 17719466 (View on PubMed)

Ho JE, Bittner V, Demicco DA, Breazna A, Deedwania PC, Waters DD. Usefulness of heart rate at rest as a predictor of mortality, hospitalization for heart failure, myocardial infarction, and stroke in patients with stable coronary heart disease (Data from the Treating to New Targets [TNT] trial). Am J Cardiol. 2010 Apr 1;105(7):905-11. doi: 10.1016/j.amjcard.2009.11.035.

Reference Type BACKGROUND
PMID: 20346304 (View on PubMed)

Kolloch R, Legler UF, Champion A, Cooper-Dehoff RM, Handberg E, Zhou Q, Pepine CJ. Impact of resting heart rate on outcomes in hypertensive patients with coronary artery disease: findings from the INternational VErapamil-SR/trandolapril STudy (INVEST). Eur Heart J. 2008 May;29(10):1327-34. doi: 10.1093/eurheartj/ehn123. Epub 2008 Mar 29.

Reference Type BACKGROUND
PMID: 18375982 (View on PubMed)

Anselmino M, Ohrvik J, Ryden L; Euro Heart Survey Investigators. Resting heart rate in patients with stable coronary artery disease and diabetes: a report from the euro heart survey on diabetes and the heart. Eur Heart J. 2010 Dec;31(24):3040-5. doi: 10.1093/eurheartj/ehq368. Epub 2010 Oct 8.

Reference Type BACKGROUND
PMID: 20935002 (View on PubMed)

Other Identifiers

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ESR-14-10413

Identifier Type: -

Identifier Source: org_study_id