The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease

NCT ID: NCT02471768

Last Updated: 2015-06-17

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

COMPLETED

Total Enrollment

623 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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Abstract

Objectives:

Primary: To study the association between central aortic blood pressure indices and coronary artery disease in patients undergoing elective angiography. Secondary: (a) To study whether any association exists between central aortic pressure indices and the incidence of major adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period. (b) To study whether any association exists between the central aortic pressures and peripheral pressures.

Methods: The investigators conducted a prospective observational study in consecutive patients undergoing coronary angiography. Central and peripheral pressures were invasively recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive group. CAD severity was graded using the Gensini score and subjects were divided into tertiles. Patients were followed up and the role of central aortic pressure indices in the prediction of cardiovascular events were analysed.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS

coronary angiogram

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective angiography for diagnosis of CAD.
* Age \> 18 years

Exclusion Criteria

* Patients with acute myocardial infarction, unstable angina or thromboembolism in the preceding 3 months.
* More than mild valvular heart disease.
* Renal impairment with serum creatinine \> 1.5 mg%.
* Unable to obtain a full study of the coronary arteries.
* Peripheral vascular occlusive disease.
* Post coronary artery bypass grafting( CABG)
* Heart rate \< 50/min and \> 120/min and other arrhythmias.
* Contraindications for coronary angiography.
* Unable to provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Medical College, Kozhikode

OTHER

Sponsor Role lead

Responsible Party

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SHREETAL RAJAN NAIR

Dr Shreetal Rajan Nair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SHREETAL R NAIR

Role: PRINCIPAL_INVESTIGATOR

Government Medical College, Kozhikode

Other Identifiers

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Ref No IRC/2013/Protocol/162

Identifier Type: -

Identifier Source: org_study_id

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