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

June 15, 2015 updated by: SHREETAL RAJAN NAIR, Government Medical College, Kozhikode

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.

Study Overview

Status

Completed

Conditions

Coronary Artery Disease

Intervention / Treatment

Procedure: CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS

Study Type

Observational

Enrollment (Actual)

623

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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6 MONTH PERIOD

Description

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

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
acute coronary syndrome(ACS) Time Frame: 6 MONTHS	6 MONTHS
stroke Time Frame: 6 months	6 months
revascularisation Time Frame: 6 months	6 months
death Time Frame: 6 months	6 months

Collaborators and Investigators

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

Sponsor

Government Medical College, Kozhikode

Investigators

Principal Investigator: SHREETAL R NAIR, Government Medical College, Kozhikode

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

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 17, 2015

Last Update Submitted That Met QC Criteria