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Surviving a Decade or More After Coronary Revascularization in a Middle Eastern Population (DECADE1+ME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491722
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group

Brief Summary:

The study will look at the cardiovascular risk factors as they arise, as well at the need for further revascularization after at least 10 years of coronary revascularization in Middle Eastern patients.

The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.


Condition or disease Intervention/treatment
Risk Factors AND Repeat Revascularization Other: risk factors and revascularization procedures

Detailed Description:

Middle Eastern patients aged 18 years or above presenting to cardiology service at one tertiary care center who had coronary revascularization (stent or coronary bypass surgery, i.e., index procedure) at least 10 years back, will interviewed to determine:

  1. Evolution of cardiovascular risk factors in the period from index procedure to time of interview. These risk factors include; hypertension, diabetes, smoking, dyslipidemia and obesity.
  2. Need for further arterial revascularization from the index procedure to time of interview.

    These arterial revascularization procedures include A. Coronary: stent and/or bypass surgery B. Carotid endarterectomy. C. peripheral arterial revascularization D. Renal artery stent.

  3. Medications used at the time if interview with special emphases on the guideline-recommended medications including antiplatelet agents, beta blockers, statins and renin angiotensin blockers.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evolution of Risk Factors and Revascularization Among >1 Decade Survivors After Coronary Revascularization in the Middle East
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 10, 2019

Intervention Details:
  • Other: risk factors and revascularization procedures
    arterial revascularizations needed since index procedure


Primary Outcome Measures :
  1. Risk factors [ Time Frame: Since index procedure to time of interview at least 10 years later ]
    Appearance of diabetes, hypertension, smoking, dyslipidemia or obesity since index procedure

  2. Arterial revascularizations [ Time Frame: Since index procedure to time of interview at least 10 years later ]
    Undergoing further coronary stent or surgery, carotid stent or surgery, lower limbs stent or surgery, and renal artery stent.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All comers who had undergone coronary stent or bypass surgery 10 years or more prior to interview. These patients will be asked about the appearance of new cardiovascular risk factors during this period and whether they had undergone further operations or procedures to the coronary arteries, carotid arteries, lower limb arteries ir renal arteries.
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Coronary stent or bypass 10 years ago or more.
  3. Dependable mental status to recall events.

Exclusion Criteria:

  1. Non coronary operations
  2. Inability to recall evnets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491722


Locations
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Jordan
Istishari Hospital
Amman, Jordan
Specialty Hospital
Amman, Jordan
Sponsors and Collaborators
Jordan Collaborating Cardiology Group

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Responsible Party: Ayman J. Hammoudeh, MD, FACC, Interventional Cardiologist, Istishari Hospital, Amman, Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier: NCT03491722    
Other Study ID Numbers: DecadeOrMoreSurvivors01
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No