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

NCT02471768 | Completed DMC

• 1 other identifier: Ref No IRC/2013/Protocol/162
• Study Type: observational
• Target: 623
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Keywords

central pressure; Gensini score; pulsatility; coronary artery disease

Outcome Measures

Primary Outcomes (4)

• acute coronary syndrome(ACS)

  6 MONTHS

• stroke

  6 months

• revascularisation

  6 months

• death

  6 months

Interventions

CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS PROCEDURE

coronary angiogram

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Medical College, Kozhikode: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• SHREETAL R NAIR

  Government Medical College, Kozhikode

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shreetal Rajan Nair

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 17, 2015

Record last verified: 2015-06