Coronary Artery DiseaseCAPCADNCT02471768
The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Government Medical College, Kozhikode.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS
- Type of treatment
- Surgery or procedure
- How many people
- 623 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6 MONTH PERIOD
Who may be able to join
- Patients undergoing elective angiography for diagnosis of CAD.
- Age > 18 years
Who cannot join
- 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)
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- Heart rate < 50/min and > 120/min and other arrhythmias.
- Contraindications for coronary angiography.
- Unable to provide written informed consent
About this study
Abstract
Objectives:
Read more
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
- Being tested
- CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS
- Keywords
- central pressure, Gensini score, pulsatility, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSISProcedure or surgery
coronary angiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
acute coronary syndrome(ACS)
Measured: 6 MONTHS
stroke
Measured: 6 months
revascularisation
Measured: 6 months
death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Kozhikode
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHREETAL RAJAN NAIR, Government Medical College, Kozhikode
- Investigators
- SHREETAL R NAIR, Principal investigator, Government Medical College, Kozhikode
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471768
- Sponsor's protocol ID
- Ref No IRC/2013/Protocol/162
- Acronym
- CAPCAD
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2015
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02471768
- Acronym / sponsor ID
- CAPCAD / Ref No IRC/2013/Protocol/162
- Conditions
- Coronary Artery Disease
- Keywords
- central pressure, Gensini score, pulsatility, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Government Medical College, KozhikodeUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6 MONTH PERIOD
Key inclusion criteria (2 listed)
- Patients undergoing elective angiography for diagnosis of CAD.
- Age > 18 years
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIScoronary angiogram | Procedure or surgery | – |
Primary outcome
acute coronary syndrome(ACS)
Time frame: 6 MONTHS
stroke
Time frame: 6 months
revascularisation
Time frame: 6 months
death
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHREETAL R NAIR principal investigator
Government Medical College, Kozhikode
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Government Medical College, Kozhikode.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute coronary syndrome(ACS) (time frame: 6 MONTHS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.