Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Current Management Status

December 7, 2016 updated by: Bassem zarif, Egyptian Cerebro-Cardio-Vascular Association

Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Their Current Status of Risk Factors Control

This study will delineate the risk profile of patients with isolated cerebral or coronary ischemia and those with combined disease. The study will also evaluate current management status of those patients and any unmet needs.This aim is proposed to be achieved by studying 3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to be 1000 patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Background: most of available data are designed to show risk profile of either coronary or cerebral ischemia, few data compared both risk profiles or tried to outline risk factors for combined ischemia.

The aim is to compare risk profile of isolated coronary, cerebral ischemia or combined disease to find out specific profile for each territory affection. Current management of risk factors will be documented to find out any unmet needs specially for sicker patients with combined ischemia.

Material and methods: 3 groups of patients representing coronary, cerebral and combined ischemia.will be studied.

Documentation of coronary ischemia will be either by history of coronary care unit admission, ECG documenting an infarction or ischemia, other noninvasive testing, previous coronary intervention or coronary artery bypass grafting. Documentation of cerebral ischemia will be by history, examination for a neurological deficit or any imaging modality documenting cerebral ischemia (brain CT, MRI or duplex whether for extra or intracranial vessels).

Risk factor analysis will be for the known risk factors like, age, sex, family history, smoking, recurrent events (like more than one coronary event), sedentary life, waist/hip ratio, BMI, diabetes(history, duration, current medication and current control status, HbA1c), hypertension (history, duration, current drug treatment and current control status). hypercholesterolemia (history, duration, drug treatment and control with current evaluation of LDL, HDL, TG, ApoB/ApoA), hs-CRP, presence of AF( drug treatment).

Full patient data will be obtained in a Case Report Form (CRF) based format. CRF format will be designed by the steering committee. Investigators at clinics or centers who agree to share, will be committed to fulfill this CRF and send electronic form to central workstation for database saving.

Filling the CRF will be based on a single interview between the investigator and the patient, and any missing data or investigation that mandates another interview will be allowed to complete the CRF within a period of 30 days.

Center or investigator agreement will be signed first to be involved in the study and to receive the CRF.

All patients will sign a written consent to share in the study.

Data analysis will be presented as mean or numbers (%). The significance of relation between qualitative variables will be analysed by chi-square test or Fisher's exact test as indicated. The distribution of means among groups will be analysed by student t testor ANOVA as appropriate.

Correlation between quantitative variables will be studied by correlation coefficient.

Independent predictors of primary outcomes will be analysed by logistic regression analysis and cox regression analysis as indicated.

.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any coronary or cerebral ischemic patients diagnosed in the ICU or at follow up in the outpatient clinics will be enrolled in the study.

Description

Inclusion Criteria:

  • Coronary ischemic patients diagnosed by history, non invasive testing, previous intervention or previous CABG.
  • Cerebral ischemic patients diagnosed by history, neurological deficit or imaging suggestive of brain ischemia or extra-cranial, intracranial arterial atherosclerotic disease.
  • Combined cerebral and coronary ischemia diagnosed by the mentioned criteria.

Exclusion Criteria:

  • Severe heart failure.
  • Severe neurological deficit .
  • Significant severe co-morbidities with multiple medications.
  • Any missing clinical, drug or laboratory data from the data needed for Case Report Form completion.
  • Any patient refused to sign to the written 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: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Group A
Having combined coronary and cerebral ischemia.
Group B
Having only coronary ischemia
group C
Having only cerebral ischemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of presence and control status for known risk factors (defined by questionnaire from history, clinical examination, laboratory testing) in each group of patients.
Time Frame: 12 months (after finishing of patients recruitment).
Number of patients in each group of having the risk factors and whether each risk factor is controlled or not?
12 months (after finishing of patients recruitment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing data of the incidence between groups (statistically) may result in a specific risk profile for combined coronary and cerebral ischemia.
Time Frame: 12 months, after calculating the incidence of risk factors in each group.
Data of the incidence of risk factors will be compared between different group.
12 months, after calculating the incidence of risk factors in each group.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovering unmet needs in controlling risk factors in our patients
Time Frame: 24 months, after revising and releasing incidence data, risk factors control will be subjected to analysis and comparison to the standard care.
Any management gap for risk factors (defined as under diagnosis, under treatment, or uncontrolled patients) will be recorded .To arise awareness of the health care system (including decision makers and public community) regarding any management gap.
24 months, after revising and releasing incidence data, risk factors control will be subjected to analysis and comparison to the standard care.

Collaborators and Investigators

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

Sponsor

Egyptian Cerebro-Cardio-Vascular Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

November 5, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 12, 2016

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECCVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

after recruiting sites and investigators.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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