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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01162902
First received: April 30, 2010
Last updated: July 13, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Stable Angina
 Drug: Diltiazem treated group
Drug: Bisoprolol treated group
Drug: Candesartan treated group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Wall to lumen ratio of fundus vessel [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    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:
  • lipid parameter [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL

  • Serum markers of inflammation [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    Measurement of change in the level of IL-6, IL-10, CRP, and MMP-9

  • Exercise capacity [ Time Frame: baseline, 1 month, and 9 months ] [ Designated as safety issue: No ]
    Measurement of change of cardiopulmonary exercise capacity

  • Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ] [ Designated as safety issue: No ]
    Measure of change of nitrate need


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hyo-Soo, Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01162902     History of Changes
Other Study ID Numbers: ABC Trial
Study First Received: April 30, 2010
Last Updated: July 13, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diltiazem
Verapamil
Candesartan
Candesartan cilexetil
Bisoprolol
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
 Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013