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

Risk Factor, Cardiovascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02989077
• Other study ID #: ECCVA
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2016
• Last updated: December 7, 2016
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: December 2016
• Source: Egyptian Cerebro-Cardio-Vascular Association
• Contact: Bassem E Badr, Doctorate
• Phone: +201223950548
• Email: bassemzarif[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Ischemia
• Ischemia, Cerebral
• Ischemia, Myocardial
• Myocardial Ischemia
• Risk Factor, Cardiovascular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Cerebro-Cardio-Vascular Association

References & Publications (3)

Emerging Risk Factors Collaboration., Di Angelantonio E, Kaptoge S, Wormser D, Willeit P, Butterworth AS, Bansal N, O'Keeffe LM, Gao P, Wood AM, Burgess S, Freitag DF, Pennells L, Peters SA, Hart CL, Håheim LL, Gillum RF, Nordestgaard BG, Psaty BM, Yeap BB, Knuiman MW, Nietert PJ, Kauhanen J, Salonen JT, Kuller LH, Simons LA, van der Schouw YT, Barrett-Connor E, Selmer R, Crespo CJ, Rodriguez B, Verschuren WM, Salomaa V, Svärdsudd K, van der Harst P, Björkelund C, Wilhelmsen L, Wallace RB, Brenner H, Amouyel P, Barr EL, Iso H, Onat A, Trevisan M, D'Agostino RB Sr, Cooper C, Kavousi M, Welin L, Roussel R, Hu FB, Sato S, Davidson KW, Howard BV, Leening MJ, Rosengren A, Dörr M, Deeg DJ, Kiechl S, Stehouwer CD, Nissinen A, Giampaoli S, Donfrancesco C, Kromhout D, Price JF, Peters A, Meade TW, Casiglia E, Lawlor DA, Gallacher J, Nagel D, Franco OH, Assmann G, Dagenais GR, Jukema JW, Sundström J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njølstad I, Hedblad B, Wassertheil-Smoller S, Engström G, Rosamond WD, Selvin E, Sattar N, Thompson SG, Danesh J. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015 Jul 7;314(1):52-60. doi: 10.1001/jama.2015.7008. Erratum in: JAMA. 2015 Sep 15;314(11):1179. Leening, Maarten [corrected to Leening, Maarten J G]. — View Citation

Soler EP, Ruiz VC. Epidemiology and risk factors of cerebral ischemia and ischemic heart diseases: similarities and differences. Curr Cardiol Rev. 2010 Aug;6(3):138-49. doi: 10.2174/157340310791658785. — View Citation

Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators.. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discovering unmet needs in controlling risk factors in our patients	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.	No
Primary	Incidence of presence and control status for known risk factors (defined by questionnaire from history, clinical examination, laboratory testing) in each group of patients.	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).	No
Secondary	Comparing data of the incidence between groups (statistically) may result in a specific risk profile for combined coronary and cerebral ischemia.	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.	No