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

NCT02989077 | Unknown DMC

• 1 other identifier: ECCVA
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemia, Myocardial; Risk Factor, Cardiovascular; Ischemia, Cerebral

Keywords

combined coronary and cerebral ischemia

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Comparing data of the incidence between groups (statistically) may result in a specific risk profile for combined coronary and cerebral ischemia.

  12 months, after calculating the incidence of risk factors in each group.

Other Outcomes (1)

• Discovering unmet needs in controlling risk factors in our patients

  24 months, after revising and releasing incidence data, risk factors control will be subjected to analysis and comparison to the standard care.

Study Arms (3)

Group A

Having combined coronary and cerebral ischemia.

Group B

Having only coronary ischemia

group C

Having only cerebral ischemia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egyptian Cerebro-Cardio-Vascular Association: lead

Related 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, Haheim 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, Svardsudd K, van der Harst P, Bjorkelund 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, Leening M, Rosengren A, Dorr 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, Sundstrom J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njolstad I, Hedblad B, Wassertheil-Smoller S, Engstrom 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.

  PMID: 26151266 BACKGROUND

• 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. doi: 10.1016/S0140-6736(04)17018-9.

  PMID: 15364185 BACKGROUND

• 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.

  PMID: 21804773 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Brain Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Bassem E Badr, Doctorate

CONTACT

+201223950548; bassemzarif@gmail.com

Marwa M Zaki, BPharm

CONTACT

+20226246160; dr.marwamamdouh@ymail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant cardiologist, Vise president of Egyptian cerebro-cardio-vascular Association

Study Record Dates

• First Submitted: November 5, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share