Ischemia, MyocardialNCT02989077
Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Current Management Status
An observational study of Ischemia, Myocardial and Risk Factor, Cardiovascular, run by Egyptian Cerebro-Cardio-Vascular Association.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ischemia, Myocardial, Risk Factor, Cardiovascular, Ischemia, Cerebral
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- How long will I take part?
- 30 Days
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
.
- Keywords
- combined coronary and cerebral ischemia
- Medical subject headings
- Myocardial Ischemia, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Having combined coronary and cerebral ischemia. | |
| Group B | Having only coronary ischemia | |
| group C | Having only cerebral ischemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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.
Data of the incidence of risk factors will be compared between different group.
Measured: 12 months, after calculating the incidence of risk factors in each group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemia, MyocardialStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Egyptian Cerebro-Cardio-Vascular Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem zarif, Egyptian Cerebro-Cardio-Vascular Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989077
- Sponsor's protocol ID
- ECCVA
- Status last verified
- Dec 2016
- First submitted
- 5 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: after recruiting sites and investigators.
Publications
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.
PubMed 26151266Yusuf 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.
PubMed 15364185Soler 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.
PubMed 21804773
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Their Current Status of Risk Factors Control
- ClinicalTrials.gov ID
- NCT02989077
- Acronym / sponsor ID
- ECCVA
- Keywords
- combined coronary and cerebral ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Egyptian Cerebro-Cardio-Vascular AssociationUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 12 Dec 2016 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Having combined coronary and cerebral ischemia. |
| Group B | – | –Having only coronary ischemia |
| group C | – | –Having only cerebral ischemia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Background: PubMed 26151266Emerging 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.
- Background: PubMed 15364185Yusuf 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.
- Background: PubMed 21804773Soler 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.
- Individual participant dataSharing planned: Yes. after recruiting sites and investigators.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, Myocardial and Risk Factor, Cardiovascular, run by Egyptian Cerebro-Cardio-Vascular Association.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassem E Badr, Doctorate (+201223950548, bassemzarif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989077, which also lists 3 linked publications.
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 12 Dec 2016.