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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02471768
Other study ID # Ref No IRC/2013/Protocol/162
Secondary ID
Status Completed
Phase N/A
First received June 8, 2015
Last updated June 15, 2015
Start date April 2014
Est. completion date June 2015

Study information

Verified date June 2015
Source Government Medical College, Kozhikode
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 623
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Procedure:
CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS
coronary angiogram

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Government Medical College, Kozhikode

Outcome

Type Measure Description Time frame Safety issue
Primary acute coronary syndrome(ACS) 6 MONTHS
Primary stroke 6 months
Primary revascularisation 6 months
Primary death 6 months
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