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Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

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ClinicalTrials.gov Identifier: NCT01162902
Recruitment Status : Unknown
Verified December 2013 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2010
Last Update Posted : December 17, 2013
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).

Condition or disease Intervention/treatment Phase
Stable Angina Drug: Diltiazem treated group Drug: Bisoprolol treated group Drug: Candesartan treated group Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Study Start Date : September 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diltiazem treated group
Diltiazem 180mg treated group
Drug: Diltiazem treated group
Diltiazem 180mg for 9 months
Active Comparator: Bisoprolol treated group
Bisoprolol 5mg treated group
Drug: Bisoprolol treated group
Bisoprolol 5mg for 9 months
Active Comparator: Candesartan treated group
Candesartan 32mg treated group
Drug: Candesartan treated group
Candesartan 32mg for 9 months



Primary Outcome Measures :
  1. Wall to lumen ratio of fundus vessel [ Time Frame: baseline, 9 months ]
    Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up


Secondary Outcome Measures :
  1. lipid parameter [ Time Frame: baseline, 9 months ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL

  2. Serum markers of inflammation [ Time Frame: baseline, 9 months ]
    CRP

  3. Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ]
    Measure of change of nitrate need



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
  • Unstable Angina/NSTEMI patients who completed PCI for main lesions
  • Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

  • STEMI patients within one month
  • Variant Angina
  • Liver function abnormality or renal failure
  • History of Hypersensitivity to testing drugs
  • Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
  • Woman possible to be pregnant
  • Uncontrolled diabetes
  • Expected life span < one year

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): NCT01162902


Contacts
Contact: Hae-Young Lee, MD, PhD 82-10-4528-6160 hylee612@snu.ac.kr
Contact: Hyo-Soo Kim, MD, PhD 82-2-2072-2226 hyosoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Hyo-Soo Kim, MD, PhD         
Sub-Investigator: Hae-Young Lee, MD,PhD         
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Hyo-Soo, Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01162902     History of Changes
Other Study ID Numbers: ABC Trial
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Angina, Stable
Vascular Remodeling
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Pathologic Processes
Candesartan
Candesartan cilexetil
Bisoprolol
Diltiazem
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents